SENTICARE PILLSTATION
FDA 510(k) clearance K103009 · decided 2011-01-28
Clearance details
- K-number
- K103009
- Device name
- SENTICARE PILLSTATION
- Applicant
- Senticare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-12
- Decision date
- 2011-01-28
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- NXQ
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PILL PHONE (K060298) | Vocel | 2006-03-29 |
Recalls involving this device
No recalls on record reference this clearance.