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FDA 510(k)

ECG-ELECTRODE(SWAROMED)

K-Number: K853939 · 1986-04-11

ApplicantD. Swarovski & Co.
Decision Date1986-04-11
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG-ELECTRODE(SWAROMED) is the device name listed in this FDA 510(k) record. The listed applicant is D. Swarovski & Co.. It received FDA 510(k) clearance on 1986-04-11 under 510(k) number K853939. 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 ECG-ELECTRODE(SWAROMED)?

ECG-ELECTRODE(SWAROMED) is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is D. Swarovski & Co.. The 510(k) number is K853939.

When did ECG-ELECTRODE(SWAROMED) receive FDA 510(k) clearance?

ECG-ELECTRODE(SWAROMED) received FDA 510(k) clearance on 1986-04-11, under 510(k) number K853939.

Who is the listed applicant for ECG-ELECTRODE(SWAROMED)?

The FDA 510(k) record lists D. Swarovski & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG-ELECTRODE(SWAROMED)?

The FDA product code for ECG-ELECTRODE(SWAROMED) is DRX.

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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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