FDA 510(k)

ROTEM DELTA THROMBOELASTOMETRY SYSTEM

K-Number: K083842 · 2010-03-23

Decision Date2010-03-23

Product CodeJPA

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ROTEM DELTA THROMBOELASTOMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pentapharm GmbH. It received FDA 510(k) clearance on 2010-03-23 under 510(k) number K083842. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTEM DELTA THROMBOELASTOMETRY SYSTEM?

ROTEM DELTA THROMBOELASTOMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-23. The listed applicant is Pentapharm GmbH. The 510(k) number is K083842.

When did ROTEM DELTA THROMBOELASTOMETRY SYSTEM receive FDA 510(k) clearance?

ROTEM DELTA THROMBOELASTOMETRY SYSTEM received FDA 510(k) clearance on 2010-03-23, under 510(k) number K083842.

Who is the listed applicant for ROTEM DELTA THROMBOELASTOMETRY SYSTEM?

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

What is the FDA product code for ROTEM DELTA THROMBOELASTOMETRY SYSTEM?

The FDA product code for ROTEM DELTA THROMBOELASTOMETRY SYSTEM is JPA.

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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.