FDA 510(k)

HEMO-DOP

K-Number: K041915 · 2004-08-04

Decision Date2004-08-04

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HEMO-DOP is the device name listed in this FDA 510(k) record. The listed applicant is Dwl Elektronische Systeme GmbH. It received FDA 510(k) clearance on 2004-08-04 under 510(k) number K041915. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-DOP?

HEMO-DOP is a medical device that received FDA 510(k) clearance on 2004-08-04. The listed applicant is Dwl Elektronische Systeme GmbH. The 510(k) number is K041915.

When did HEMO-DOP receive FDA 510(k) clearance?

HEMO-DOP received FDA 510(k) clearance on 2004-08-04, under 510(k) number K041915.

Who is the listed applicant for HEMO-DOP?

The FDA 510(k) record lists Dwl Elektronische Systeme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMO-DOP?

The FDA product code for HEMO-DOP is IYN.

Related Devices (Code: IYN)

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.

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.