SoftSpot
FDA 510(k) clearance K212045 · decided 2021-09-28
Clearance details
- K-number
- K212045
- Device name
- SoftSpot
- Applicant
- Pediametrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-30
- Decision date
- 2021-09-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QQO
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.