데이터베이스 소개
국제 의료기기 데이터베이스 사용법
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FAQ
출처표기
Manufacturers
Minolta Corp
제조사 주소
Minolta Corp, 101 Williams Dr, Ramsey NJ 07446-1217
Source
USFDA
2 Events
Device Recall Pulsox 의 리콜
Device Recall Pulsox 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 2 건
Device Recall Pulsox
모델명 / 제조번호(시리얼번호)
Model 3Si, Serial Nos: 22001453-22001469; 22001471-22001512; 22001514-22001599; 22001600-22001626; 22001628-22001632; 22001635-22001643; 22001645-22001651; 22001653-22001659; 22001661-22001676; 22001678-22001683; 22001685-22001686; 22001688-22001691; 22001712-22001714; 22001717-22001719; 22001721-22001723; 22001725; 22001727-22001732; 22001734-22001737; 22001740-22001745; 22001747-22001765; 22001767-22001770; 22001772; 22001776; 22001860; 22001862; 22001865; 22001868; 22001879; 22001881; 22001882; 22001885; 22001887; 22001893; 22001897; 22001899; 22001905.
의료기기 분류등급
Anesthesiology Devices
의료기기 등급
2
이식된 장치?
No
유통
The units were shipped to one distributor in Utah.
제품 설명
Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-site, Patient range adult to neonatal, memory function Approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hours, size: 42x68x20mm, weight 42g.
Device Recall Pulsox
모델명 / 제조번호(시리얼번호)
Model 3iA, Serial Nos.: 23001201; 23001204; 23001206; 23001210; 23001212-23001214; 23001216; 23001217.
의료기기 분류등급
Anesthesiology Devices
의료기기 등급
2
이식된 장치?
No
유통
The units were shipped to one distributor in Utah.
제품 설명
Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accuracy Sp02 +/-2% (70 to 100), pulse rate +/- 2, Sp02 alarm, audible and visible, probe type finger, multi-site, paitent range adult to neonatal, memory function approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hrs, size 42x68x20mm, weight 42g.
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