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FDA 510(k)

Pediarity™

K-Number: K231531 · 2023-12-21

ApplicantHinlab, Inc.
Decision Date2023-12-21
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pediarity™ is the device name listed in this FDA 510(k) record. The listed applicant is Hinlab, Inc.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K231531. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pediarity™?

Pediarity™ is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Hinlab, Inc.. The 510(k) number is K231531.

When did Pediarity™ receive FDA 510(k) clearance?

Pediarity™ received FDA 510(k) clearance on 2023-12-21, under 510(k) number K231531.

Who is the listed applicant for Pediarity™?

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

What is the FDA product code for Pediarity™?

The FDA product code for Pediarity™ is DQA.

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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