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FDA 510(k)

HEARTRATE METER MODEL 650, P/N 000119

K-Number: K772097 · 1977-11-22

ApplicantQuinton, Inc.
Decision Date1977-11-22
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTRATE METER MODEL 650, P/N 000119 is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1977-11-22 under 510(k) number K772097. 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 HEARTRATE METER MODEL 650, P/N 000119?

HEARTRATE METER MODEL 650, P/N 000119 is a medical device that received FDA 510(k) clearance on 1977-11-22. The listed applicant is Quinton, Inc.. The 510(k) number is K772097.

When did HEARTRATE METER MODEL 650, P/N 000119 receive FDA 510(k) clearance?

HEARTRATE METER MODEL 650, P/N 000119 received FDA 510(k) clearance on 1977-11-22, under 510(k) number K772097.

Who is the listed applicant for HEARTRATE METER MODEL 650, P/N 000119?

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

What is the FDA product code for HEARTRATE METER MODEL 650, P/N 000119?

The FDA product code for HEARTRATE METER MODEL 650, P/N 000119 is DRT.

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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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