510(k) K974285
- Device
- PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
- Applicant
- PERIMED, INC.
- 510(k) number
- K974285
- Product code
- DPW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-05-28
- Date received
- 1997-11-14
- Regulation
- 870.2100
- Classification name
- Flowmeter, Blood, Cardiovascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KJELL BAKKEN
- Address
- 821 W. Jericho Tpke. Suite A Smithtown NY US 11787 11787
FDA Registration Numbers#
- 8020605
- 3003971136
- 1416980
- 2183870
- 3010405299
- 3017636737
- 1047843
- 8010762
- 3007427881
- 9680225
- 3003993690
- 3020115
- 3007014520
- 1062741
- 1000589001
- 1221072
- 1319639
- 3010390468
- 3015151147
- 3003647374
- 3003730855
- 1000393132
- 9613067
- 9680933
- 2183967
- 1820334
- 3004871905
- 9615583
- 3003144120
- 1056553
- 2434008
- 1216677
- 8043564
- 3009265194
- 3015139886
- 3043198445
- 1937397
- 1319030
- 3006169981
- 9611033
- 2183744
- 8030885
- 1124841
- 3009507273
Source Documents#
Other 510(k) Records For Product Code DPW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252810 | FloPatch FP120 | Flosonics Medical | 2026-04-24 |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | Remington Medical, Inc. | 2025-11-20 |
| K251114 | FloPatch FP120 | Flosonics Medical | 2025-06-20 |
| K243852 | Elfor-L | Elfi-Tech , Ltd. | 2025-04-14 |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) | Remington Medical, Inc. | 2024-08-30 |
| K223843 | FloPatch FP120 | Flosonics Medical | 2023-05-03 |
| K222242 | FloPatch FP120 | Flosonics Medical | 2022-12-09 |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | Synovis Micro Companies Alliance, Inc. | 2022-04-20 |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | Remington Medical, Inc. | 2022-01-27 |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Remington Medical, Inc. | 2021-10-07 |
| K201114 | Bidop 7 | Koven Technology, Inc. | 2021-01-05 |
| K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020-03-24 |
| K192966 | FlowMet | Laser Associated Sciences, Inc. | 2020-01-10 |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare , Ltd. | 2019-09-06 |
| K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2019-06-21 |
Legacy Summary#
summary
FDA Review#
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