The following data is part of a premarket notification filed by Analytica Ltd with the FDA for Pericoach.
Device ID | K143580 |
510k Number | K143580 |
Device Name: | PeriCoach |
Classification | Perineometer |
Applicant | ANALYTICA LTD 320 ADELAIDE STREET Brisbane, AU 4000 |
Contact | Geoff Daly |
Correspondent | Tracey Bullivant Brandwood Biomedical 408, 406 Pacific Highway St Leonards, AU 2065 |
Product Code | HIR |
CFR Regulation Number | 884.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-18 |
Decision Date | 2015-03-18 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PERICOACH 79135113 4607665 Live/Registered |
Analytica Limited 2013-07-22 |