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FDA 510(k)

MODEL DS-504 DYNASCOPE PATIENT MONITOR

K-Number: K893405 · 1989-10-02

ApplicantFukuda Denshi USA, Inc.
Decision Date1989-10-02
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL DS-504 DYNASCOPE PATIENT MONITOR 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 1989-10-02 under 510(k) number K893405. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL DS-504 DYNASCOPE PATIENT MONITOR?

MODEL DS-504 DYNASCOPE PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 1989-10-02. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K893405.

When did MODEL DS-504 DYNASCOPE PATIENT MONITOR receive FDA 510(k) clearance?

MODEL DS-504 DYNASCOPE PATIENT MONITOR received FDA 510(k) clearance on 1989-10-02, under 510(k) number K893405.

Who is the listed applicant for MODEL DS-504 DYNASCOPE PATIENT MONITOR?

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 MODEL DS-504 DYNASCOPE PATIENT MONITOR?

The FDA product code for MODEL DS-504 DYNASCOPE PATIENT MONITOR is DRT.

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Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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