Home / 510(k) Clearances / K980960

510(k) K980960

IN-CHECK INSPIRATORY FLOWMETER by Clement Clarke Intl., Ltd. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1998
Date Received
March 16, 1998
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 Clement Clarke Intl., Ltd.

  • K053156 — MINI-WRIGHT DIGITAL, MODEL 3120001 (January 31, 2006)
  • K042058 — ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN (March 23, 2005)
  • K000368 — EYECAP IMAGING SYSTEM (May 4, 2000)
  • K982334 — AIRZONE PEAK FLOWMETER (January 14, 1999)
  • K962074 — VM PLUS PEAK FLOWMETER (January 2, 1997)

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)