3 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·February 7, 2024
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
FDA Enforcement
Class I
·Terminated·Nidek Medical Products Inc·June 27, 2012
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
FDA Enforcement
Class I
·Terminated·Nidek Medical Products Inc·June 27, 2012