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FDA 510(k)

ANNE Pediatric

K-Number: K221530 · 2022-11-22

ApplicantSibel, Inc.
Decision Date2022-11-22
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANNE Pediatric is a medical device manufactured by Sibel, Inc.. It received FDA 510(k) clearance on 2022-11-22 under approval 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. It is manufactured by Sibel, Inc.. The 510(k) number is K221530.

When was ANNE Pediatric approved by the FDA?

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

What company makes ANNE Pediatric?

ANNE Pediatric is manufactured by Sibel, Inc..

What is the FDA product code for ANNE Pediatric?

The FDA product code for ANNE Pediatric is DRG.

Other Devices by Sibel, Inc.

K211305ANNE One K220095ANNE Sleep

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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.

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