Home / 510(k) Clearances / K030586

510(k) K030586

MICROPEAK by Micro Direct, Inc. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2003
Date Received
February 24, 2003
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 Micro Direct, Inc.

  • K033688 — MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY (May 19, 2004)
  • K031102 — MICROLAB SPIROMETER (December 1, 2003)
  • K973314 — SPIROSAFE FILTER (November 21, 1997)
  • K965042 — MICRODL DIARYCARD SPIROMETER (June 17, 1997)
  • K963376 — MICRO H2 (January 24, 1997)
  • K963035 — MICRO SPIROMETER (November 1, 1996)
  • K950197 — MICROCO (October 17, 1996)
  • K940375 — MICRO MPM (November 21, 1994)

Other clearances for product code BZH

  • 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)
  • K203196 — Peak flow meter (May 26, 2021)
  • 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)
  • K181666 — Smart One (August 1, 2018)