510(k) K212045
K212045 is an FDA 510(k) premarket notification submitted by Pediametrix, Inc. for the device "SoftSpot". The FDA issued a decision of Substantially Equivalent on September 28, 2021. The device falls under product code QQO (Cranial Measurement Software), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2021
- Date Received
- June 30, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cranial Measurement Software
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- NE
- Submission Type
Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods.