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510(k) K844333

SPIROMETRICS 2451 & SMI I by Spirometrics, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1984
Date Received
November 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

Other clearances by Spirometrics, Inc.

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  • K901057 — SPIROMETRICS MODEL 2600 MIRO SPIROMETER (April 3, 1990)
  • K900673 — SERIAL FLOW (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)
  • K831497 — SPIROMETRICS BREON 2400 & SMI 2400 (June 24, 1983)

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