FDA 510(k)

4000 ETM

K-Number: K960296 · 1996-02-20

Decision Date1996-02-20

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

4000 ETM is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1996-02-20 under 510(k) number K960296. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4000 ETM?

4000 ETM is a medical device that received FDA 510(k) clearance on 1996-02-20. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K960296.

When did 4000 ETM receive FDA 510(k) clearance?

4000 ETM received FDA 510(k) clearance on 1996-02-20, under 510(k) number K960296.

Who is the listed applicant for 4000 ETM?

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

What is the FDA product code for 4000 ETM?

The FDA product code for 4000 ETM is GEI.

Other records listing Aspen Laboratories, Inc. as applicant

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.

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Official Source

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