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510(k) K921565

CARDIOPULMONARY METABOLIC MEASUEMENT CART by Quiton Instrument Co. — Product Code BZL

K921565 is an FDA 510(k) premarket notification submitted by Quiton Instrument Co. for the device "CARDIOPULMONARY METABOLIC MEASUEMENT CART". The FDA issued a decision of Substantially Equivalent on August 11, 1994. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1994
Date Received
April 1, 1992
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

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  • 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