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FDA 510(k)

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167

K-Number: K080712 · 2008-05-06

ApplicantSerim Research Corp.
Decision Date2008-05-06
Product CodeMSY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research Corp.. It received FDA 510(k) clearance on 2008-05-06 under 510(k) number K080712. The device is classified under product code MSY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIM HISENSE ULTRA 0.1, PART NUMBER 5167?

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 is a medical device that received FDA 510(k) clearance on 2008-05-06. The listed applicant is Serim Research Corp.. The 510(k) number is K080712.

When did SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 receive FDA 510(k) clearance?

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 received FDA 510(k) clearance on 2008-05-06, under 510(k) number K080712.

Who is the listed applicant for SERIM HISENSE ULTRA 0.1, PART NUMBER 5167?

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

What is the FDA product code for SERIM HISENSE ULTRA 0.1, PART NUMBER 5167?

The FDA product code for SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 is MSY.

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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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