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FDA 510(k)

FUTUREMED ECG SYSTEM 500

K-Number: K862381 · 1986-07-17

ApplicantFuturemed Div. of Future Impex Corp.
Decision Date1986-07-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUTUREMED ECG SYSTEM 500 is the device name listed in this FDA 510(k) record. The listed applicant is Futuremed Div. of Future Impex Corp.. It received FDA 510(k) clearance on 1986-07-17 under 510(k) number K862381. 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 FUTUREMED ECG SYSTEM 500?

FUTUREMED ECG SYSTEM 500 is a medical device that received FDA 510(k) clearance on 1986-07-17. The listed applicant is Futuremed Div. of Future Impex Corp.. The 510(k) number is K862381.

When did FUTUREMED ECG SYSTEM 500 receive FDA 510(k) clearance?

FUTUREMED ECG SYSTEM 500 received FDA 510(k) clearance on 1986-07-17, under 510(k) number K862381.

Who is the listed applicant for FUTUREMED ECG SYSTEM 500?

The FDA 510(k) record lists Futuremed Div. of Future Impex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUTUREMED ECG SYSTEM 500?

The FDA product code for FUTUREMED ECG SYSTEM 500 is DPS.

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Other records listing Futuremed Div. of Future Impex Corp. 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.

K933511UPGRADED SPIROMETER ST-90K933220SELECTOR SL 01K933222AUDIOMETER DA 323K903017MEGA-TENS DUAL CHANNEL T.E.N.S.K901308SPIRO ANALYZER MODEL ST 250K884972TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR

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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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