FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BED PADS: D-12 AND D-8
K Number: K781404
·
Decision Sep 7, 1978
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
1
Review Days
28
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BED PADS: D-12 AND D-8
- K Number
- K781404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Grant Airmass Corp.
- Date Received
- August 10, 1978
- Decision Date
- September 7, 1978
- Product Code
- FNM
- 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 |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FNM), ordered by most recent decision date.
PRESSURE GUARD SITE SELECT (A)
FDA 510(k)
FDA Class 2
·General Hospital
MIGHTY AIR
FDA 510(k)
FDA Class 2
·General Hospital
ZAK-2000
FDA 510(k)
FDA Class 2
·General Hospital
PHYSIO/1000
FDA 510(k)
FDA Class 2
·General Hospital
SIMPULSE
FDA 510(k)
FDA Class 2
·General Hospital
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital