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FDA 510(k)

INFANT ELECTRODE BELT

K-Number: K830362 · 1983-06-03

ApplicantSentry Medical Products, Inc.
Decision Date1983-06-03
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFANT ELECTRODE BELT is the device name listed in this FDA 510(k) record. The listed applicant is Sentry Medical Products, Inc.. It received FDA 510(k) clearance on 1983-06-03 under 510(k) number K830362. 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 INFANT ELECTRODE BELT?

INFANT ELECTRODE BELT is a medical device that received FDA 510(k) clearance on 1983-06-03. The listed applicant is Sentry Medical Products, Inc.. The 510(k) number is K830362.

When did INFANT ELECTRODE BELT receive FDA 510(k) clearance?

INFANT ELECTRODE BELT received FDA 510(k) clearance on 1983-06-03, under 510(k) number K830362.

Who is the listed applicant for INFANT ELECTRODE BELT?

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

What is the FDA product code for INFANT ELECTRODE BELT?

The FDA product code for INFANT ELECTRODE BELT is DRX.

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Other records listing Sentry Medical Products, 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.

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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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