FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARK-5 CONCENTRATOR
K Number: K883591
·
Decision Nov 2, 1988
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
12
Review Days
71
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Basic Information
- Device Name
- MARK-5 CONCENTRATOR
- K Number
- K883591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Nidek Medical Products, Inc.
- Date Received
- August 23, 1988
- Decision Date
- November 2, 1988
- Product Code
- CAW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
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Other Clearances by Nidek Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K192693 | Nuvo Nano Portable Oxygen Concentrator | May 7, 2020 | Substantially Equivalent |
| K123738 | MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD | Feb 28, 2013 | Substantially Equivalent |
| K093308 | MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD | Jan 14, 2010 | Substantially Equivalent |
| K082566 | MARK 5 NUVO LITE OCSI AND STD | Dec 3, 2008 | Substantially Equivalent |
| K040892 | MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 | Apr 29, 2004 | Substantially Equivalent |
| K032509 | MARK 5 NUVO (M5C5) | Mar 18, 2004 | Substantially Equivalent |
| K020797 | PULMO-MIST COMPRESSOR MODEL # 4323 | May 3, 2002 | Substantially Equivalent |
| K980551 | SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | Nov 17, 1998 | Substantially Equivalent |
| K962492 | SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | Jan 23, 1997 | Substantially Equivalent |
| K952966 | CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | May 7, 1996 | Substantially Equivalent |