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510(k) K936110

ASPIRE by Dura Pharmaceuticals, Inc. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1995
Date Received
December 23, 1993
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 Dura Pharmaceuticals, Inc.

  • K896984 — PARI I.S.-2 (March 9, 1990)
  • K894555 — PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED (January 24, 1990)

Other clearances for product code BZH

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  • 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)