FDA 510(k) Applications Submitted by Nidek Medical Products, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K980551 |
02/12/1998 |
SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
NIDEK MEDICAL PRODUCTS, INC. |
| K962492 |
06/26/1996 |
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
NIDEK MEDICAL PRODUCTS, INC. |
| K952966 |
06/27/1995 |
CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
NIDEK MEDICAL PRODUCTS, INC. |
| K040892 |
04/06/2004 |
MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 |
NIDEK MEDICAL PRODUCTS, INC. |
| K032509 |
08/14/2003 |
MARK 5 NUVO (M5C5) |
NIDEK MEDICAL PRODUCTS, INC. |
| K082566 |
09/04/2008 |
MARK 5 NUVO LITE OCSI AND STD |
NIDEK MEDICAL PRODUCTS, INC. |
| K093308 |
10/22/2009 |
MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD |
NIDEK MEDICAL PRODUCTS, INC. |
| K020797 |
03/12/2002 |
PULMO-MIST COMPRESSOR MODEL # 4323 |
NIDEK MEDICAL PRODUCTS, INC. |
| K192693 |
09/26/2019 |
Nuvo Nano Portable Oxygen Concentrator |
Nidek Medical Products, Inc. |
| K123738 |
12/05/2012 |
MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD |
NIDEK MEDICAL PRODUCTS, INC. |
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