510(k) DEN170049
- Device
- Innovo
- Applicant
- Bio-Medical Research, Ltd.
- 510(k) number
- DEN170049
- Product code
- QAJ
- Decision
- Unknown (DENG)
- Decision date
- 2018-11-06
- Date received
- 2017-09-18
- Regulation
- 876.5330
- Classification name
- Cutaneous Electrode Stimulator For Urinary Incontinence
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Anne-Marie Keenan
- Address
- Parkmore Business Park W. Galway IE H91NHT7 H91NHT7
FDA Registration Numbers#
- 3003990090
- 3014915464
Source Documents#
510(k) summary PDF not indicated by FDA