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510(k) K915059

PEAK FLOW MONITOR by Spirometrics, Inc. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1992
Date Received
November 8, 1991
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 Spirometrics, Inc.

  • K911358 — CMD/DLCO DIAGNOSTIC SPIROMETER (July 22, 1991)
  • K900322 — CO/CMD-1 (April 30, 1990)
  • K900673 — SERIAL FLOW (April 3, 1990)
  • K901057 — SPIROMETRICS MODEL 2600 MIRO SPIROMETER (April 3, 1990)
  • K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR (January 19, 1989)
  • K884465 — SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM) (November 9, 1988)
  • K863953 — SPIROMETRICS MODEL 2500 FLOWMATE(TM) (January 15, 1987)
  • K850045 — SPIROMETRICS 2453 & SMI III (February 14, 1985)
  • K844333 — SPIROMETRICS 2451 & SMI I (November 20, 1984)
  • K831497 — SPIROMETRICS BREON 2400 & SMI 2400 (June 24, 1983)

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