FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT
K Number: K881632
·
Decision Sep 26, 1988
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
23
Review Days
165
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Basic Information
- Device Name
- FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT
- K Number
- K881632
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Huntleigh Technology, Inc.
- Date Received
- April 14, 1988
- Decision Date
- September 26, 1988
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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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 |
| K874688 | FLOWTRON AC200/2 | Sep 23, 1988 | Substantially Equivalent |
| K882644 | HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 | Aug 10, 1988 | Substantially Equivalent |