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510(k) K211305

ANNE One by Sibel, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2021
Date Received
April 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by Sibel, Inc.

  • K221530 — ANNE Pediatric (November 22, 2022)
  • K220095 — ANNE Sleep (July 11, 2022)

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  • K241101 — BioButton System (September 26, 2024)
  • K240251 — ANNE Chest (June 3, 2024)
  • K223711 — ANNE One (August 10, 2023)
  • K220526 — HD+12, HD+15 (May 15, 2023)
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