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FDA 510(k)

C.E. VASCULAR MACHINE

K-Number: K960840 · 1997-03-28

ApplicantC.E. Diagnosis, Inc.
Decision Date1997-03-28
Product CodeJEH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

C.E. VASCULAR MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is C.E. Diagnosis, Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K960840. The device is classified under product code JEH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C.E. VASCULAR MACHINE?

C.E. VASCULAR MACHINE is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is C.E. Diagnosis, Inc.. The 510(k) number is K960840.

When did C.E. VASCULAR MACHINE receive FDA 510(k) clearance?

C.E. VASCULAR MACHINE received FDA 510(k) clearance on 1997-03-28, under 510(k) number K960840.

Who is the listed applicant for C.E. VASCULAR MACHINE?

The FDA 510(k) record lists C.E. Diagnosis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C.E. VASCULAR MACHINE?

The FDA product code for C.E. VASCULAR MACHINE is JEH.

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Related Devices (Code: JEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240706PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)Ganshorn Medizin Electronic GmbHK223818Model 9160 VitaloQUBVitalograph Ireland, Ltd.K072061MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODYViasys Healthcare GmbHK022636BODY BOX 5500Morgan Scientific, Inc.K953642AP-18Jeneric/Pentron, Inc.K951901MASTERSCREEN PFT BODYErich Jaeger GmbH & Co. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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