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FDA 510(k)

BIODAN TYPE COMET ELECTRODE

K-Number: K871668 · 1987-06-10

ApplicantNational Medical Technology
Decision Date1987-06-10
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIODAN TYPE COMET ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Technology. It received FDA 510(k) clearance on 1987-06-10 under 510(k) number K871668. 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 BIODAN TYPE COMET ELECTRODE?

BIODAN TYPE COMET ELECTRODE is a medical device that received FDA 510(k) clearance on 1987-06-10. The listed applicant is National Medical Technology. The 510(k) number is K871668.

When did BIODAN TYPE COMET ELECTRODE receive FDA 510(k) clearance?

BIODAN TYPE COMET ELECTRODE received FDA 510(k) clearance on 1987-06-10, under 510(k) number K871668.

Who is the listed applicant for BIODAN TYPE COMET ELECTRODE?

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

What is the FDA product code for BIODAN TYPE COMET ELECTRODE?

The FDA product code for BIODAN TYPE COMET ELECTRODE is DRX.

Related Clinical Trials

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.

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Other records listing National Medical Technology 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.

K861158S&W TYPE 888 ELECTRODEK830888COOL-LITE FIBERCOPTIC LARYNGEAL EXAMK790845DUALUME LARYNGEAL EXAMINATION TELESCOPE

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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