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510(k) K190792

BB-613WP by Biobeat Technologies , Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2019
Date Received
March 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Biobeat Technologies , Ltd.

  • K241066 — BB-613-BPM (January 14, 2025)
  • K222010 — Biobeat Platform-2 and BB-613WP Patch (December 30, 2022)
  • K212153 — Biobeat Platform, BB-613WP Patch (March 25, 2022)

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