FDA 510(k)

FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M

K-Number: K083697 · 2009-03-19

Decision Date2009-03-19

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 2009-03-19 under 510(k) number K083697. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M?

FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M is a medical device that received FDA 510(k) clearance on 2009-03-19. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K083697.

When did FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M receive FDA 510(k) clearance?

FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M received FDA 510(k) clearance on 2009-03-19, under 510(k) number K083697.

Who is the listed applicant for FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M?

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

What is the FDA product code for FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M?

The FDA product code for FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M is MHX.

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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.