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510(k) K960840

C.E. VASCULAR MACHINE by C.E. Diagnosis, Inc. — Product Code JEH

K960840 is an FDA 510(k) premarket notification submitted by C.E. Diagnosis, Inc. for the device "C.E. VASCULAR MACHINE". The FDA issued a decision of Substantially Equivalent on March 28, 1997. The device falls under product code JEH (Plethysmograph, Volume), a Class II device regulated under 21 CFR 868.1760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1997
Date Received
February 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Volume
Device Class
Class II
Regulation Number
868.1760
Review Panel
AN
Submission Type

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  • K953642 — AP-18 (December 12, 1995)
  • K951901 — MASTERSCREEN PFT BODY (July 31, 1995)
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  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)

FDA data resources