510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960840Substantially Equivalent

C.e. Vascular Machine

C.E. Diagnosis, Inc., East Ellijay GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960840 is the FDA 510(k) clearance record for C.E. VASCULAR MACHINE, a class II device, cleared for C.E. Diagnosis, Inc. on under FDA product code JEH (Plethysmograph, Volume). FDA records list one 510(k) clearance for C.E. Diagnosis, Inc. As of , FDA records show no recalls naming K960840.

Clearance record

Decision date
Received
(393 days to decision)
Product code
JEH Plethysmograph, Volume
Regulation
21 CFR 868.1760
Device class
Class II
Review panel
Anesthesiology
Applicant
C.E. Diagnosis, Inc. One Mulberry St., East Ellijay GA
510(k) summary
Statement
Third party review
No

Clearances, product code JEH

Trailing 12 months

FDA records hold no clearances under product code JEH in the trailing twelve months.

FDA records show no clearances under product code JEH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JEH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260