The following data is part of a premarket notification filed by Analytica Ltd. with the FDA for Pericoach Otc.
| Device ID | K160758 |
| 510k Number | K160758 |
| Device Name: | PeriCoach OTC |
| Classification | Perineometer |
| Applicant | ANALYTICA LTD. 320 ADELAIDE STREET Brisbane, AU 4000 |
| Contact | Geoff Daly |
| Correspondent | Tammy Ahmadzada BRANDWOOD BIOMEDICAL SUITE 5, LEVEL 9, 1 CHANDOS STREET 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 | 2016-03-18 |
| Decision Date | 2016-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09338067000581 | K160758 | 000 |