FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
4LYF OXYGEN CONCENTRATOR
K Number: K872534
·
Decision Oct 13, 1987
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
18
Review Days
109
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Basic Information
- Device Name
- 4LYF OXYGEN CONCENTRATOR
- K Number
- K872534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Airsep Corp.
- Date Received
- June 26, 1987
- Decision Date
- October 13, 1987
- 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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| K992283 | ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | Aug 27, 1999 | Substantially Equivalent |
| K983002 | MYSTIQUE ULTRASONIC NEBULIZER | Oct 16, 1998 | Substantially Equivalent |