Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SoftSpot

K-Number: K212045 · 2021-09-28

ApplicantPediametrix, Inc.
Decision Date2021-09-28
Product CodeQQO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SoftSpot is a medical device manufactured by Pediametrix, Inc.. It received FDA 510(k) clearance on 2021-09-28 under approval number K212045. The device is classified under product code QQO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SoftSpot?

SoftSpot is a medical device that received FDA 510(k) clearance on 2021-09-28. It is manufactured by Pediametrix, Inc.. The 510(k) number is K212045.

When was SoftSpot approved by the FDA?

SoftSpot received FDA 510(k) clearance on 2021-09-28, under approval number K212045.

What company makes SoftSpot?

SoftSpot is manufactured by Pediametrix, Inc..

What is the FDA product code for SoftSpot?

The FDA product code for SoftSpot is QQO.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑