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 |