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510(k) K922660

PHYSIO-DYNE EASI - LAB by Physio-Dyne — Product Code BZL

K922660 is an FDA 510(k) premarket notification submitted by Physio-Dyne for the device "PHYSIO-DYNE EASI - LAB". The FDA issued a decision of Substantially Equivalent on April 8, 1993. 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
April 8, 1993
Date Received
June 3, 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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  • K021490 — REEVUE INDIRECT CALORIMETER, MODEL#8100 (January 2, 2003)
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FDA data resources