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FDA 510(k)

THROMBO TEK PSE, MODEL 90-480

K-Number: K082631 · 2008-12-17

ApplicantR2 Diagnostics, Inc.
Decision Date2008-12-17
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBO TEK PSE, MODEL 90-480 is the device name listed in this FDA 510(k) record. The listed applicant is R2 Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-12-17 under 510(k) number K082631. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBO TEK PSE, MODEL 90-480?

THROMBO TEK PSE, MODEL 90-480 is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is R2 Diagnostics, Inc.. The 510(k) number is K082631.

When did THROMBO TEK PSE, MODEL 90-480 receive FDA 510(k) clearance?

THROMBO TEK PSE, MODEL 90-480 received FDA 510(k) clearance on 2008-12-17, under 510(k) number K082631.

Who is the listed applicant for THROMBO TEK PSE, MODEL 90-480?

The FDA 510(k) record lists R2 Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THROMBO TEK PSE, MODEL 90-480?

The FDA product code for THROMBO TEK PSE, MODEL 90-480 is GGP.

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Official Source

View on FDA Database →

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

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