FDA 510(k)

HEPTRAC ELECTRONIC QUALITY CONTROL

K-Number: K981815 · 1998-07-30

Decision Date1998-07-30

Product CodeJPA

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HEPTRAC ELECTRONIC QUALITY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Blood Management. It received FDA 510(k) clearance on 1998-07-30 under 510(k) number K981815. 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 HEPTRAC ELECTRONIC QUALITY CONTROL?

HEPTRAC ELECTRONIC QUALITY CONTROL is a medical device that received FDA 510(k) clearance on 1998-07-30. The listed applicant is Medtronic Blood Management. The 510(k) number is K981815.

When did HEPTRAC ELECTRONIC QUALITY CONTROL receive FDA 510(k) clearance?

HEPTRAC ELECTRONIC QUALITY CONTROL received FDA 510(k) clearance on 1998-07-30, under 510(k) number K981815.

Who is the listed applicant for HEPTRAC ELECTRONIC QUALITY CONTROL?

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

What is the FDA product code for HEPTRAC ELECTRONIC QUALITY CONTROL?

The FDA product code for HEPTRAC ELECTRONIC QUALITY CONTROL is JPA.

Related Clinical Trials

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Other records listing Medtronic Blood Management as applicant

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Related Devices (Code: 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.