Huntleigh Technology, Inc.
Walker, MI, US
Huntleigh Technology, Inc. appears in FDA device records in Walker, MI. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Huntleigh Technology, Inc. between 1981 and 1999. The busiest year on record is 1985, with 4. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 3 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 1 |
| 1993 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992733 | AKRON ATP9 TRACTION MACHINE | ITH | Substantially Equivalent | |
| K964699 | RHEO DOPPLEX II (RD 2) | IYN | Substantially Equivalent | |
| K924516 | OP3/VP4 | HGL | Substantially Equivalent | |
| K910188 | FLOWPLUS AC330 PUMP GARMENTS | JOW | Substantially Equivalent | |
| K900882 | MULTI DOPPLEX, MD-1 | JAF | Substantially Equivalent | |
| K900618 | HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 | KNG | Substantially Equivalent | |
| K890012 | HUNTLEIGH DYNAMIC FLOTATION SYSTEM | FNM | Substantially Equivalent | |
| K884451 | DOPCORD PPG | JOM | Substantially Equivalent | |
| K881632 | FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT | JOW | Substantially Equivalent | |
| K874688 | FLOWTRON AC200/2 | IRP | Substantially Equivalent | |
| K882644 | HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 | FNM | Substantially Equivalent | |
| K871271 | HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR. | DRM | Substantially Equivalent | |
| K871272 | HUNTLEIGH FLOWPAC FP2000 | DRM | Substantially Equivalent | |
| K870681 | HUNTLEIGH BETA II HM85 | FNM | Substantially Equivalent | |
| K854267 | HUNTLEIGH DOPCORD, D140 | KNG | Substantially Equivalent | |
| K850945 | HUNTLEIGH FLOWTRON AIR HAND GARMENT, HG300 | Substantially Equivalent | ||
| K850910 | HUNTLEIGH FLOWTRON AIR, AC400/2 AIR | Substantially Equivalent | ||
| K844880 | HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES | FNM | Substantially Equivalent | |
| K844879 | HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP | FNM | Substantially Equivalent | |
| K834399 | NEW MOTHER'S WAY-BREAST PUMP | HGY | Substantially Equivalent | |
| K823188 | M2000 INTRAPARTUM FETAL MONITOR | HGM | Substantially Equivalent | |
| K823081 | M2100 ANTEPARTUM FETAL MONITOR | HGM | Substantially Equivalent | |
| K810115 | DOPPLEX-PLB & PXB | KNG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DRMCompressor, Cardiac, External
- ITHEquipment, Traction, Powered
- IRPMassager, Powered Inflatable Tube
- FNMMattress, Air Flotation, Alternating Pressure
- KNGMonitor, Ultrasonic, Fetal
- JAFMonitor, Ultrasonic, Nonfetal
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
- HGYPump, Breast, Non-Powered
- JOWSleeve, Limb, Compressible
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- HGMSystem, Monitoring, Perinatal
- HGLTransducer, Ultrasonic, Obstetric
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain