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510(k) K191614

BioSticker System by Biointellisense, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2019
Date Received
June 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Biointellisense, Inc.

  • K241101 — BioButton System (September 26, 2024)

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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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