The following data is part of a premarket notification filed by Huntleigh Healthcare Ltd. with the FDA for Smartsigns Minpulse.
| Device ID | K081572 |
| 510k Number | K081572 |
| Device Name: | SMARTSIGNS MINPULSE |
| Classification | Oximeter |
| Applicant | HUNTLEIGH HEALTHCARE LTD. 35 PORTMANMOOR RD. Cardiff, South Glamorgan, GB Cf24 5hn |
| Contact | Robert Mccarthy |
| Correspondent | Robert Mccarthy HUNTLEIGH HEALTHCARE LTD. 35 PORTMANMOOR RD. Cardiff, South Glamorgan, GB Cf24 5hn |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-04 |
| Decision Date | 2008-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968022264 | K081572 | 000 |
| 05051968022240 | K081572 | 000 |