The following data is part of a premarket notification filed by Huntleigh Healthcare Limited with the FDA for Sonicaid Freedom Wireless Fetal Monitoring System.
Device ID | K132650 |
510k Number | K132650 |
Device Name: | SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM |
Classification | System, Monitoring, Perinatal |
Applicant | HUNTLEIGH HEALTHCARE LIMITED 35 PORTMANMOOR ROAD Cardiff, Wales, GB Cf24 5hn |
Contact | Laura Garcia Deacon |
Correspondent | Laura Garcia Deacon HUNTLEIGH HEALTHCARE LIMITED 35 PORTMANMOOR ROAD Cardiff, Wales, GB Cf24 5hn |
Product Code | HGM |
CFR Regulation Number | 884.2740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-26 |
Decision Date | 2014-02-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05051968032416 | K132650 | 000 |
05051968032409 | K132650 | 000 |
05051968032133 | K132650 | 000 |
05051968042057 | K132650 | 000 |