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510(k) K840741

PULMONARY FUNCTION TESTING STS by Circadian, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1984
Date Received
February 1, 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 Circadian, Inc.

  • K921878 — SCANMATE III (September 11, 1992)
  • K894956 — CIRCAMED HOLTER VERSION 4 (February 5, 1990)
  • K874641 — CIRCADIAN STRESS TEST II (April 1, 1988)
  • K874155 — CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (November 23, 1987)
  • K871251 — CIRCAMED FULL DISCLOSURE SYSTEM (May 22, 1987)
  • K860973 — CIRCADIAN STRESS TEST SYSTEM (August 25, 1986)
  • K851517 — CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO (October 2, 1985)
  • K851643 — REMOTE CONTROL MODULE (September 9, 1985)
  • K833619 — CONDUCTANCE METER (January 27, 1984)
  • K830830 — CIRCA MED TWO-CHANNEL (June 18, 1983)

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