FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
K Number: K882644
·
Decision Aug 10, 1988
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
23
Review Days
44
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
- HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
- K Number
- K882644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Huntleigh Technology, Inc.
- Date Received
- June 27, 1988
- Decision Date
- August 10, 1988
- 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
Other Clearances by Huntleigh Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992733 | AKRON ATP9 TRACTION MACHINE | Nov 10, 1999 | Substantially Equivalent |
| K964699 | RHEO DOPPLEX II (RD 2) | Feb 21, 1997 | Substantially Equivalent |
| K924516 | OP3/VP4 | Jun 28, 1993 | Substantially Equivalent |
| K910188 | FLOWPLUS AC330 PUMP GARMENTS | May 28, 1991 | Substantially Equivalent |
| K900882 | MULTI DOPPLEX, MD-1 | Aug 22, 1990 | Substantially Equivalent |
| K900618 | HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 | Apr 25, 1990 | Substantially Equivalent |
| K890012 | HUNTLEIGH DYNAMIC FLOTATION SYSTEM | Mar 29, 1989 | Substantially Equivalent |
| K884451 | DOPCORD PPG | Jan 12, 1989 | Substantially Equivalent |
| K881632 | FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT | Sep 26, 1988 | Substantially Equivalent |
| K874688 | FLOWTRON AC200/2 | Sep 23, 1988 | Substantially Equivalent |