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FDA 510(k)

ELECTROCARDIOGRAPHIC ELECTRODES, DISP.

K-Number: K770521 · 1977-03-29

ApplicantDobre, Inc.
Decision Date1977-03-29
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPHIC ELECTRODES, DISP. is the device name listed in this FDA 510(k) record. The listed applicant is Dobre, Inc.. It received FDA 510(k) clearance on 1977-03-29 under 510(k) number K770521. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROCARDIOGRAPHIC ELECTRODES, DISP.?

ELECTROCARDIOGRAPHIC ELECTRODES, DISP. is a medical device that received FDA 510(k) clearance on 1977-03-29. The listed applicant is Dobre, Inc.. The 510(k) number is K770521.

When did ELECTROCARDIOGRAPHIC ELECTRODES, DISP. receive FDA 510(k) clearance?

ELECTROCARDIOGRAPHIC ELECTRODES, DISP. received FDA 510(k) clearance on 1977-03-29, under 510(k) number K770521.

Who is the listed applicant for ELECTROCARDIOGRAPHIC ELECTRODES, DISP.?

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

What is the FDA product code for ELECTROCARDIOGRAPHIC ELECTRODES, DISP.?

The FDA product code for ELECTROCARDIOGRAPHIC ELECTRODES, DISP. is DRX.

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Other records listing Dobre, 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.

K924891PLEXUS PULSER I, PLEXUS PULSER II

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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