Comfortpro
FDA 510(k) clearance K212438 · decided 2021-12-07
Clearance details
- K-number
- K212438
- Device name
- Comfortpro
- Applicant
- Thai Rubber Industry Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2021-08-04
- Decision date
- 2021-12-07
- Days to decision
- 125 days
- Clearance type
- Abbreviated
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Pluakdaeng, TH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.