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510(k) K220095

ANNE Sleep by Sibel, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2022
Date Received
January 12, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Sibel, Inc.

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  • K211305 — ANNE One (September 14, 2021)

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