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FDA 510(k)

ENGSTROM HMEF 1000

K-Number: K964204 · 1996-11-13

ApplicantDatex Engstrom AB
Decision Date1996-11-13
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENGSTROM HMEF 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Datex Engstrom AB. It received FDA 510(k) clearance on 1996-11-13 under 510(k) number K964204. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGSTROM HMEF 1000?

ENGSTROM HMEF 1000 is a medical device that received FDA 510(k) clearance on 1996-11-13. The listed applicant is Datex Engstrom AB. The 510(k) number is K964204.

When did ENGSTROM HMEF 1000 receive FDA 510(k) clearance?

ENGSTROM HMEF 1000 received FDA 510(k) clearance on 1996-11-13, under 510(k) number K964204.

Who is the listed applicant for ENGSTROM HMEF 1000?

The FDA 510(k) record lists Datex Engstrom AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENGSTROM HMEF 1000?

The FDA product code for ENGSTROM HMEF 1000 is CAH.

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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.

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