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FDA 510(k)

OMNIGRAPH 4000(ELECTROCARDIOGRAPH)

K-Number: K852652 · 1985-11-19

ApplicantTelemed Div.
Decision Date1985-11-19
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNIGRAPH 4000(ELECTROCARDIOGRAPH) is the device name listed in this FDA 510(k) record. The listed applicant is Telemed Div.. It received FDA 510(k) clearance on 1985-11-19 under 510(k) number K852652. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIGRAPH 4000(ELECTROCARDIOGRAPH)?

OMNIGRAPH 4000(ELECTROCARDIOGRAPH) is a medical device that received FDA 510(k) clearance on 1985-11-19. The listed applicant is Telemed Div.. The 510(k) number is K852652.

When did OMNIGRAPH 4000(ELECTROCARDIOGRAPH) receive FDA 510(k) clearance?

OMNIGRAPH 4000(ELECTROCARDIOGRAPH) received FDA 510(k) clearance on 1985-11-19, under 510(k) number K852652.

Who is the listed applicant for OMNIGRAPH 4000(ELECTROCARDIOGRAPH)?

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 4000(ELECTROCARDIOGRAPH)?

The FDA product code for OMNIGRAPH 4000(ELECTROCARDIOGRAPH) is DRS.

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.

K880357OMNIGRAPH 6000

Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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