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FDA 510(k)

DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM

K-Number: K950470 · 1995-11-06

ApplicantNikomed U.S.A., Inc.
Decision Date1995-11-06
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM is the device name listed in this FDA 510(k) record. The listed applicant is Nikomed U.S.A., Inc.. It received FDA 510(k) clearance on 1995-11-06 under 510(k) number K950470. 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 DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM?

DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM is a medical device that received FDA 510(k) clearance on 1995-11-06. The listed applicant is Nikomed U.S.A., Inc.. The 510(k) number is K950470.

When did DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM receive FDA 510(k) clearance?

DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM received FDA 510(k) clearance on 1995-11-06, under 510(k) number K950470.

Who is the listed applicant for DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM?

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

What is the FDA product code for DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM?

The FDA product code for DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM is DRX.

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Other records listing Nikomed U.S.A., 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.

K022909NIKOMED TRACE 1 ECG ELECTRODESK000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MK950473DISPOSABLE ECG MONITORING ELECTRODEK950472DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MMK950475DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540K950480DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM

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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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