SoftSpot— 510(k) K212045
Substantially EquivalentPediametrix, Inc.
FDA 510(k) clearance K212045 for SoftSpot, Substantially Equivalent on 2021-09-28. Applicant: Pediametrix, Inc.. Device class: 1.
Clearance details
- Applicant
- Pediametrix, Inc.
- Product code
- Code QQO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.