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FDA 510(k)

PIONEER II BACK PLATE ELECTRODE

K-Number: K820122 · 1982-03-01

ApplicantLife Science Instrumentation, Inc.
Decision Date1982-03-01
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PIONEER II BACK PLATE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Life Science Instrumentation, Inc.. It received FDA 510(k) clearance on 1982-03-01 under 510(k) number K820122. 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 PIONEER II BACK PLATE ELECTRODE?

PIONEER II BACK PLATE ELECTRODE is a medical device that received FDA 510(k) clearance on 1982-03-01. The listed applicant is Life Science Instrumentation, Inc.. The 510(k) number is K820122.

When did PIONEER II BACK PLATE ELECTRODE receive FDA 510(k) clearance?

PIONEER II BACK PLATE ELECTRODE received FDA 510(k) clearance on 1982-03-01, under 510(k) number K820122.

Who is the listed applicant for PIONEER II BACK PLATE ELECTRODE?

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

What is the FDA product code for PIONEER II BACK PLATE ELECTRODE?

The FDA product code for PIONEER II BACK PLATE ELECTRODE is DRX.

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Other records listing Life Science Instrumentation, Inc. as applicant

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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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