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FDA 510(k)

POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES

K-Number: K885262 · 1989-01-25

ApplicantValleylab, Inc.
Decision Date1989-01-25
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 1989-01-25 under 510(k) number K885262. 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 POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES?

POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES is a medical device that received FDA 510(k) clearance on 1989-01-25. The listed applicant is Valleylab, Inc.. The 510(k) number is K885262.

When did POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES receive FDA 510(k) clearance?

POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES received FDA 510(k) clearance on 1989-01-25, under 510(k) number K885262.

Who is the listed applicant for POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES?

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

What is the FDA product code for POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES?

The FDA product code for POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES is DRX.

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Other records listing Valleylab, 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.

K031011LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500K010010VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATORK010013LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODEK983743BISURE LAPAROSCOPIC BIPOLAR FORCEPSK981916LIGASURE VESSEL SEALING SYSTEM

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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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