FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONSUMMATE AIR THERAPY BED
K Number: K890426
·
Decision Apr 5, 1989
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
69
Applicant Total
13
Review Days
69
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Basic Information
- Device Name
- CONSUMMATE AIR THERAPY BED
- K Number
- K890426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5100
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Health Products, Inc.
- Date Received
- January 26, 1989
- Decision Date
- April 5, 1989
- Product Code
- FNL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | FDA class 2 | General Hospital |
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| K896953 | MODIFIED ASSESS(R) PEAK FLOW METER | Jan 30, 1990 | Substantially Equivalent |
| K894353 | ORTHODERM CONVERTIBLE | Aug 9, 1989 | Substantially Equivalent |
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| K871742 | MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER | Jun 15, 1987 | Substantially Equivalent |
| K870514 | THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER | Mar 31, 1987 | Substantially Equivalent |
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