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FDA 510(k)

CSS-60 DIGITAL HEART RATE METER

K-Number: K780702 · 1978-05-19

ApplicantBurdick Corp.
Decision Date1978-05-19
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CSS-60 DIGITAL HEART RATE METER is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1978-05-19 under 510(k) number K780702. 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 CSS-60 DIGITAL HEART RATE METER?

CSS-60 DIGITAL HEART RATE METER is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Burdick Corp.. The 510(k) number is K780702.

When did CSS-60 DIGITAL HEART RATE METER receive FDA 510(k) clearance?

CSS-60 DIGITAL HEART RATE METER received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780702.

Who is the listed applicant for CSS-60 DIGITAL HEART RATE METER?

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

What is the FDA product code for CSS-60 DIGITAL HEART RATE METER?

The FDA product code for CSS-60 DIGITAL HEART RATE METER is DRT.

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Other records listing Burdick Corp. as applicant

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K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK904032ELITE II ELECTROCARDIOGRAPHK903565E560 ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840L

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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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