510(k) DEN220065
- Device
- Pill Sense System
- Applicant
- Enterasense , Ltd.
- 510(k) number
- DEN220065
- Product code
- QUD
- Decision
- Unknown (DENG)
- Decision date
- 2023-02-24
- Date received
- 2022-09-29
- Regulation
- 876.1390
- Classification name
- Blood Detection Capsule
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- David Collins
- Address
- Unit 3 Ballybrit Business Park, Mervue Galway IE H91 DT7C H91 DT7C
FDA Registration Numbers#
- 3027502350
- 3007766601
- 3005580113
Source Documents#
510(k) summary PDF not indicated by FDA