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Minolta Corp

Ramsey, NJ

Minolta Corp appears in FDA device records in Ramsey, NJ. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

No FDA product codes recorded against this company.

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0290-04Pulsox-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.Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.Terminated
Z-0289-04Pulsox-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.Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain