The following data is part of a De Novo classification by Bio-medical Research Ltd. with the FDA for Innovo.
DeNovo ID | DEN170049 |
Device Name: | Innovo |
Classification | Cutaneous Electrode Stimulator For Urinary Incontinence |
Applicant | Bio-Medical Research Ltd. parkmore Business Park West Galway, IE H91nht7 |
Contact | Anne-marie Keenan |
Product Code | QAJ |
CFR Regulation Number | 876.5330 [🔎] |
Decision | Granted (DENG) |
501(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Gastroenterology/Urology |
Classification Advisory | Gastroenterology/Urology |
Type | Direct |
Date Received | 2017-09-18 |
Decision Date | 2018-11-06 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15391533470494 | DEN170049 | 000 |
15391533470487 | DEN170049 | 000 |
15391533470470 | DEN170049 | 000 |
15391533470463 | DEN170049 | 000 |
15391533470456 | DEN170049 | 000 |
15391533470449 | DEN170049 | 000 |
15391533470432 | DEN170049 | 000 |
15391533470425 | DEN170049 | 000 |
15391533470418 | DEN170049 | 000 |