FDA 510(k)

ANNE Pediatric

K-Number: K221530 · 2022-11-22

Decision Date2022-11-22

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ANNE Pediatric is the device name listed in this FDA 510(k) record. The listed applicant is Sibel, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221530. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANNE Pediatric?

ANNE Pediatric is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Sibel, Inc.. The 510(k) number is K221530.

When did ANNE Pediatric receive FDA 510(k) clearance?

ANNE Pediatric received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221530.

Who is the listed applicant for ANNE Pediatric?

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

What is the FDA product code for ANNE Pediatric?

The FDA product code for ANNE Pediatric is DRG.

Other records listing Sibel, Inc. as applicant

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.

K220095ANNE Sleep K211305ANNE One

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Official Source

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