FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEGABED 1000
K Number: K872925
·
Decision Sep 15, 1987
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
69
Applicant Total
5
Review Days
50
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Basic Information
- Device Name
- MEGABED 1000
- K Number
- K872925
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5100
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Surgi-Med, Inc.
- Date Received
- July 27, 1987
- Decision Date
- September 15, 1987
- 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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Other Clearances by Surgi-Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881705 | MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM | Jul 13, 1988 | Substantially Equivalent |
| K873047 | KEANE MOBILITY BED | Oct 15, 1987 | Substantially Equivalent |
| K872923 | PARAGON 9000 TILT AND TURN BED | Oct 14, 1987 | Substantially Equivalent |
| K872924 | PARAGON 8500 CARDIO-PULMONARY BED | Oct 9, 1987 | Substantially Equivalent |