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FDA 510(k)

FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR

K-Number: K875057 · 1988-03-22

ApplicantFukuda Denshi USA, Inc.
Decision Date1988-03-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA MODEL DS-503 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 1988-03-22 under 510(k) number K875057. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR?

FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 1988-03-22. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K875057.

When did FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR receive FDA 510(k) clearance?

FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR received FDA 510(k) clearance on 1988-03-22, under 510(k) number K875057.

Who is the listed applicant for FUKUDA MODEL DS-503 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 FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR?

The FDA product code for FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR is DPS.

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Other records listing Fukuda Denshi USA, Inc. as applicant

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Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

Official Source

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

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