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FDA 510(k)

OMNIGRAPH 6000

K-Number: K880357 · 1988-08-02

ApplicantTelemed Div.
Decision Date1988-08-02
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNIGRAPH 6000 is the device name listed in this FDA 510(k) record. The listed applicant is Telemed Div.. It received FDA 510(k) clearance on 1988-08-02 under 510(k) number K880357. 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 OMNIGRAPH 6000?

OMNIGRAPH 6000 is a medical device that received FDA 510(k) clearance on 1988-08-02. The listed applicant is Telemed Div.. The 510(k) number is K880357.

When did OMNIGRAPH 6000 receive FDA 510(k) clearance?

OMNIGRAPH 6000 received FDA 510(k) clearance on 1988-08-02, under 510(k) number K880357.

Who is the listed applicant for OMNIGRAPH 6000?

The FDA 510(k) record lists Telemed Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNIGRAPH 6000?

The FDA product code for OMNIGRAPH 6000 is DPS.

Related Clinical Trials

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.

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Other records listing Telemed Div. 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.

K852652OMNIGRAPH 4000(ELECTROCARDIOGRAPH)

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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