Pill Sense System
FDA 510(k) clearance DEN220065 · decided 2023-02-24
Clearance details
- K-number
- DEN220065
- Device name
- Pill Sense System
- Applicant
- Enterasense , Ltd.
- Decision
- Unknown
- Date received
- 2022-09-29
- Decision date
- 2023-02-24
- Days to decision
- 148 days
- Clearance type
- Direct
- Product code
- QUD
- Device class
- 2
- Regulation number
- 876.1390
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.