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FDA 510(k)

MONITOR, HEART RATE MODEL 103

K-Number: K782089 · 1979-01-04

ApplicantRoche Medical Electronics, Inc.
Decision Date1979-01-04
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITOR, HEART RATE MODEL 103 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Medical Electronics, Inc.. It received FDA 510(k) clearance on 1979-01-04 under 510(k) number K782089. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, HEART RATE MODEL 103?

MONITOR, HEART RATE MODEL 103 is a medical device that received FDA 510(k) clearance on 1979-01-04. The listed applicant is Roche Medical Electronics, Inc.. The 510(k) number is K782089.

When did MONITOR, HEART RATE MODEL 103 receive FDA 510(k) clearance?

MONITOR, HEART RATE MODEL 103 received FDA 510(k) clearance on 1979-01-04, under 510(k) number K782089.

Who is the listed applicant for MONITOR, HEART RATE MODEL 103?

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

What is the FDA product code for MONITOR, HEART RATE MODEL 103?

The FDA product code for MONITOR, HEART RATE MODEL 103 is DRT.

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Other records listing Roche Medical Electronics, 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.

K791559ROCHE SENSOR ADAPTORK791038FETASONDE UTERINE ACTIVITY MONITORK791037FETASONDE LABOR STATUS DISPLAYK791039FETASONDE FETAL HEART RATE VARIABILITYK791035FETASONDE FETAL ACTIVITY MONITORK791036FETASONDE UTERINE WORK MONITOR

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Related Devices (Code: DRT)

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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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