FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIGHTY AIR
K Number: K974319
·
Decision Jan 22, 1998
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
4
Review Days
66
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
- MIGHTY AIR
- K Number
- K974319
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wheelchairs of Kansas
- Date Received
- November 17, 1997
- Decision Date
- January 22, 1998
- 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
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
BARIAIR
FDA 510(k)
FDA Class 2
·General Hospital