Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Pediametrix, Inc.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) 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. The listed applicant is Pediametrix, Inc.. The 510(k) number is K212045.

When did SoftSpot receive FDA 510(k) clearance?

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

Who is the listed applicant for SoftSpot?

The FDA 510(k) record lists Pediametrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

↑