FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFESTYLE OXYGEN CONCENTRATOR
K Number: K020324
·
Decision Mar 13, 2002
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
18
Review Days
41
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Basic Information
- Device Name
- LIFESTYLE OXYGEN CONCENTRATOR
- K Number
- K020324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Airsep Corp.
- Date Received
- January 31, 2002
- Decision Date
- March 13, 2002
- 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 Airsep Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K101154 | CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L | Mar 28, 2011 | Substantially Equivalent |
| K080348 | OXISCAN II DATA MANAGEMENT SYSTEM | Oct 9, 2008 | Substantially Equivalent |
| K012037 | HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 | Jan 17, 2002 | Substantially Equivalent |
| K000963 | DA VINCHI EEG AND EMG/EP SYSTEMS | Oct 20, 2000 | Substantially Equivalent |
| K001579 | IMPULSE SELECT | Aug 31, 2000 | Substantially Equivalent |
| K001467 | DA VINCHI EMG/EP ISA1004EP | Aug 1, 2000 | Substantially Equivalent |
| K001013 | MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | May 16, 2000 | Substantially Equivalent |
| K992283 | ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | Aug 27, 1999 | Substantially Equivalent |
| K983002 | MYSTIQUE ULTRASONIC NEBULIZER | Oct 16, 1998 | Substantially Equivalent |
| K960309 | AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) | Feb 28, 1997 | Substantially Equivalent |