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FDA 510(k)

PACEART WRIST ELECTRODES

K-Number: K960721 · 1996-07-18

ApplicantPaceart, Inc.
Decision Date1996-07-18
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEART WRIST ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Paceart, Inc.. It received FDA 510(k) clearance on 1996-07-18 under 510(k) number K960721. 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 PACEART WRIST ELECTRODES?

PACEART WRIST ELECTRODES is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is Paceart, Inc.. The 510(k) number is K960721.

When did PACEART WRIST ELECTRODES receive FDA 510(k) clearance?

PACEART WRIST ELECTRODES received FDA 510(k) clearance on 1996-07-18, under 510(k) number K960721.

Who is the listed applicant for PACEART WRIST ELECTRODES?

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

What is the FDA product code for PACEART WRIST ELECTRODES?

The FDA product code for PACEART WRIST ELECTRODES is DRX.

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Other records listing Paceart, 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.

K012407PACEART TX3 CARDIAC EVENT RECORDERK982090PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEMK973141HEART ACCESS PLUS CARDIAC EVENT RECORDERK952065PACEART CARDIOVOICEK931296PACEART CARDIOPHONEK915632PACEART CPTS-86/12

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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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