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510(k) K831780

METABOLIC EXERCISE TESTING SYSTEM by Warren E. Collins, Inc. — Product Code BZL

K831780 is an FDA 510(k) premarket notification submitted by Warren E. Collins, Inc. for the device "METABOLIC EXERCISE TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Warren E. Collins, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
June 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Oxygen-Uptake
Device Class
Class II
Regulation Number
868.1730
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)
  • K831778 — RS-RESIDUAL VOLUME SYSTEM (August 31, 1983)
  • K831777 — COLLINS DS (August 31, 1983)
  • K831779 — COLLINS EAGLE II (August 26, 1983)
  • K803053 — APEXLINE OF PULMONARY FUNCT. INSTRUM. (December 22, 1980)
  • K803069 — SHELL KRATON THERMO-PLASTIC RUBBER COMP. (December 22, 1980)

Other clearances for product code BZL

  • K200076 — Breezing Med (September 25, 2020)
  • K190561 — NICU V'02 (September 4, 2020)
  • K110810 — ANASCIENT BREATH MONITOR (June 21, 2011)
  • K093080 — METAPHOR METABOLIC MONITOR (January 22, 2010)
  • K071533 — FITMATE SERIES (September 28, 2007)
  • K070858 — EXPRESS SERIES (April 16, 2007)
  • K061731 — MEDGRAPHICS ULTIMA SYSTEM (September 6, 2006)
  • K021490 — REEVUE INDIRECT CALORIMETER, MODEL#8100 (January 2, 2003)
  • K021605 — MEDGEM (June 14, 2002)
  • K010577 — BODYGEM, MODEL HB211 (January 10, 2002)

FDA data resources