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FDA 510(k)

MODIFICATION TO DYNASCOPE SERIES MONITORS

K-Number: K863914 · 1987-01-06

ApplicantFukuda Denshi USA, Inc.
Decision Date1987-01-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO DYNASCOPE SERIES MONITORS 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 1987-01-06 under 510(k) number K863914. 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 MODIFICATION TO DYNASCOPE SERIES MONITORS?

MODIFICATION TO DYNASCOPE SERIES MONITORS is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K863914.

When did MODIFICATION TO DYNASCOPE SERIES MONITORS receive FDA 510(k) clearance?

MODIFICATION TO DYNASCOPE SERIES MONITORS received FDA 510(k) clearance on 1987-01-06, under 510(k) number K863914.

Who is the listed applicant for MODIFICATION TO DYNASCOPE SERIES MONITORS?

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 MODIFICATION TO DYNASCOPE SERIES MONITORS?

The FDA product code for MODIFICATION TO DYNASCOPE SERIES MONITORS is DPS.

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Other records listing Fukuda Denshi USA, Inc. as applicant

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.

K173226CardiMax ElectrocardiographK112521FUKUDA DENSHI VASERA MODEL VS-1500K103134FUKUDA DENSHIK083697FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210MK082656MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNITK081891FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR

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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

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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