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FDA 510(k)

ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO

K-Number: K894648 · 1989-09-05

ApplicantArbo Medical, Inc.
Decision Date1989-09-05
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO is the device name listed in this FDA 510(k) record. The listed applicant is Arbo Medical, Inc.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K894648. 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 ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO?

ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Arbo Medical, Inc.. The 510(k) number is K894648.

When did ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO receive FDA 510(k) clearance?

ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO received FDA 510(k) clearance on 1989-09-05, under 510(k) number K894648.

Who is the listed applicant for ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO?

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

What is the FDA product code for ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO?

The FDA product code for ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO is DRX.

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Other records listing Arbo Medical, 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.

K940323ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEMK935437ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODESK942905DISPOSABLE TEMPERATURE PROBE COVERK940302ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEMK940322ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIREK935246ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES

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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

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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