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510(k) K203196

Peak flow meter by Shanghai Sonmol Medical Equipment Co., Ltd. — Product Code BZH

K203196 is an FDA 510(k) premarket notification submitted by Shanghai Sonmol Medical Equipment Co., Ltd. for the device "Peak flow meter". The FDA issued a decision of Substantially Equivalent on May 26, 2021. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2021
Date Received
October 28, 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 for product code BZH

  • K253180 — Microlife Digital Peak Flow Meter, Model PF200B (PF200B) (June 23, 2026)
  • K252802 — Peak Flow Meter (PF-10(BR-PEF231)) (May 29, 2026)
  • K241338 — Peak Flow Meter (December 31, 2024)
  • K232588 — Aluna 2 (November 25, 2024)
  • K230423 — Electronic Peak Flow Meter (February 23, 2024)
  • K222810 — TD-7301 Peak Flow meter (December 19, 2023)
  • K200832 — Safey Peak Flow Meter (July 30, 2020)
  • K193311 — Aluna (March 25, 2020)
  • K191239 — Smart Peak Flow Meter (December 6, 2019)
  • K180487 — Peak.me (October 26, 2018)

FDA data resources