510(k) K212045
- Device
- SoftSpot
- Applicant
- Pediametrix, Inc.
- 510(k) number
- K212045
- Product code
- QQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-28
- Date received
- 2021-06-30
- Regulation
- 878.4800
- Classification name
- Cranial Measurement Software
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Joshua D Levin
- Address
- 155 Gibbs St., Suite 537 Rockville MD US 20850 20850
FDA Registration Numbers
- 3036758969
- 3037007857
- 3020857381