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FDA 510(k)

BOWEN REUSEABLE/DISPOSABLE ELECTRODE

K-Number: K871325 · 1987-06-08

ApplicantBowen & Company, Inc.
Decision Date1987-06-08
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOWEN REUSEABLE/DISPOSABLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Bowen & Company, Inc.. It received FDA 510(k) clearance on 1987-06-08 under 510(k) number K871325. 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 BOWEN REUSEABLE/DISPOSABLE ELECTRODE?

BOWEN REUSEABLE/DISPOSABLE ELECTRODE is a medical device that received FDA 510(k) clearance on 1987-06-08. The listed applicant is Bowen & Company, Inc.. The 510(k) number is K871325.

When did BOWEN REUSEABLE/DISPOSABLE ELECTRODE receive FDA 510(k) clearance?

BOWEN REUSEABLE/DISPOSABLE ELECTRODE received FDA 510(k) clearance on 1987-06-08, under 510(k) number K871325.

Who is the listed applicant for BOWEN REUSEABLE/DISPOSABLE ELECTRODE?

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

What is the FDA product code for BOWEN REUSEABLE/DISPOSABLE ELECTRODE?

The FDA product code for BOWEN REUSEABLE/DISPOSABLE ELECTRODE is DRX.

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Other records listing Bowen & Company, 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.

K896898BOWEN ELECTRODE SKIN PREPATORY CLEANSERK896538DISPOSABLE 45 DEGREE SHAVERK873766STERNAL POWER AWLK872098CREMEEN ALVEOLAR BONE CALIPERK87088245 DEGREE SHAVERK870881LOOSE BODY GRASPERS

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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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