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510(k) K803053

APEXLINE OF PULMONARY FUNCT. INSTRUM. by Warren E. Collins, Inc. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
December 2, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Predicted Values, Pulmonary Function
Device Class
Class II
Regulation Number
868.1890
Review Panel
AN
Submission Type

Other clearances by Warren E. Collins, Inc.

  • K925459 — GS-MODULAR (GOLD STANDARD - MODULAR) (February 4, 1994)
  • K912946 — COLLINS DIGITAL PULMONARY MANOMETER (January 15, 1992)
  • K871151 — THE SPIRA ELEKTRO 2 (May 15, 1987)
  • K861227 — COLLINS PNEUMOTACH PFT SYSTEM (June 5, 1986)
  • K852102 — COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM (July 31, 1985)
  • K831780 — METABOLIC EXERCISE TESTING SYSTEM (September 12, 1983)
  • K831778 — RS-RESIDUAL VOLUME SYSTEM (August 31, 1983)
  • K831777 — COLLINS DS (August 31, 1983)
  • K831779 — COLLINS EAGLE II (August 26, 1983)
  • K803069 — SHELL KRATON THERMO-PLASTIC RUBBER COMP. (December 22, 1980)

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