The following data is part of a premarket notification filed by Huntleigh Healthcare Ltd with the FDA for Srx Handheld Doppler, Dmx Handheld Doppler, Obstetric Probes, Vascular Probes.
| Device ID | K183574 |
| 510k Number | K183574 |
| Device Name: | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff, GB Cf24 5hn |
| Contact | Steve Monks |
| Correspondent | Steve Monks Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff, GB Cf24 5hn |
| Product Code | DPW |
| Subsequent Product Code | HGL |
| Subsequent Product Code | JAF |
| Subsequent Product Code | JOM |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968041326 | K183574 | 000 |
| 05051968041340 | K183574 | 000 |
| 05051968041357 | K183574 | 000 |
| 05051968041364 | K183574 | 000 |
| 05051968041395 | K183574 | 000 |
| 05051968041401 | K183574 | 000 |
| 05051968041418 | K183574 | 000 |
| 05051968041265 | K183574 | 000 |
| 05051968041272 | K183574 | 000 |
| 05051968041289 | K183574 | 000 |
| 05051968041296 | K183574 | 000 |
| 05051968041302 | K183574 | 000 |
| 05051968041319 | K183574 | 000 |
| 05051968044501 | K183574 | 000 |