C.E. VASCULAR MACHINE— 510(k) K960840

Substantially Equivalent

C.E. Diagnosis, Inc.

FDA 510(k) clearance K960840 for C.E. VASCULAR MACHINE, Substantially Equivalent on 1997-03-28. Applicant: C.E. Diagnosis, Inc.. Device class: 2.

Clearance details

Applicant: C.E. Diagnosis, Inc.
Product code: Code JEH
Device class: Class 2
Regulation: 21 CFR 868.1760
Advisory panel: Anesthesiology
Date received: 1996-02-29
Decision date: 1997-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Ellijay, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JEH

K240706 — PowerCube+ Series (3 models)2024-12-09
K223818 — Model 9160 VitaloQUB2023-05-25
K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY2008-04-22
K022636 — BODY BOX 55002003-01-13
K953642 — AP-181995-12-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.