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FDA 510(k)

DYNASCOPE MONITOR DS-800

K-Number: K844348 · 1984-12-04

ApplicantFukuda Denshi USA, Inc.
Decision Date1984-12-04
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DYNASCOPE MONITOR DS-800 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 1984-12-04 under 510(k) number K844348. 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 DYNASCOPE MONITOR DS-800?

DYNASCOPE MONITOR DS-800 is a medical device that received FDA 510(k) clearance on 1984-12-04. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K844348.

When did DYNASCOPE MONITOR DS-800 receive FDA 510(k) clearance?

DYNASCOPE MONITOR DS-800 received FDA 510(k) clearance on 1984-12-04, under 510(k) number K844348.

Who is the listed applicant for DYNASCOPE MONITOR DS-800?

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 DYNASCOPE MONITOR DS-800?

The FDA product code for DYNASCOPE MONITOR DS-800 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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