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FDA 510(k)

ANNE Sleep

K-Number: K220095 · 2022-07-11

ApplicantSibel, Inc.
Decision Date2022-07-11
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANNE Sleep is a medical device manufactured by Sibel, Inc.. It received FDA 510(k) clearance on 2022-07-11 under approval number K220095. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANNE Sleep?

ANNE Sleep is a medical device that received FDA 510(k) clearance on 2022-07-11. It is manufactured by Sibel, Inc.. The 510(k) number is K220095.

When was ANNE Sleep approved by the FDA?

ANNE Sleep received FDA 510(k) clearance on 2022-07-11, under approval number K220095.

What company makes ANNE Sleep?

ANNE Sleep is manufactured by Sibel, Inc..

What is the FDA product code for ANNE Sleep?

The FDA product code for ANNE Sleep is MNR.

Other Devices by Sibel, Inc.

K211305ANNE One K221530ANNE Pediatric

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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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