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510(k) K200832

Safey Peak Flow Meter by Safey Medical Devices Pvt, Ltd. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2020
Date Received
March 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

Other clearances by Safey Medical Devices Pvt, Ltd.

  • K201002 — Safey Pocket Spirometer (July 30, 2020)

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  • K203196 — Peak flow meter (May 26, 2021)
  • K193311 — Aluna (March 25, 2020)
  • K191239 — Smart Peak Flow Meter (December 6, 2019)
  • K180487 — Peak.me (October 26, 2018)
  • K181666 — Smart One (August 1, 2018)
  • K172804 — Besmed Peak Flow Meter (January 11, 2018)