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510(k) K780328

PULMONARY FUNCTION TESTER, COMPUTERIZED by Warren E. Collins, Inc. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1978
Date Received
February 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
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)
  • K831777 — COLLINS DS (August 31, 1983)
  • K831778 — RS-RESIDUAL VOLUME SYSTEM (August 31, 1983)
  • K831779 — COLLINS EAGLE II (August 26, 1983)
  • K803053 — APEXLINE OF PULMONARY FUNCT. INSTRUM. (December 22, 1980)

Other clearances for product code BZC

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  • K190853 — Vyntus BODY (August 16, 2019)
  • K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable (November 30, 2018)
  • K162515 — COSMED K5 Wearable Metabolic Technology (June 20, 2017)
  • K161295 — MiniBox + (October 21, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)