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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 the device name listed in this FDA 510(k) record. The listed applicant is Sibel, Inc.. It received FDA 510(k) clearance on 2022-07-11 under 510(k) 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. The listed applicant is Sibel, Inc.. The 510(k) number is K220095.

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

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

Who is the listed applicant for ANNE Sleep?

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 Sleep?

The FDA product code for ANNE Sleep is MNR.

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.

Related Devices (Code: MNR)

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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