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FDA 510(k)

SURGIPULSE HEART RATE MONITOR

K-Number: K771199 · 1977-07-25

ApplicantStryker Corp.
Decision Date1977-07-25
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SURGIPULSE HEART RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1977-07-25 under 510(k) number K771199. 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 SURGIPULSE HEART RATE MONITOR?

SURGIPULSE HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 1977-07-25. The listed applicant is Stryker Corp.. The 510(k) number is K771199.

When did SURGIPULSE HEART RATE MONITOR receive FDA 510(k) clearance?

SURGIPULSE HEART RATE MONITOR received FDA 510(k) clearance on 1977-07-25, under 510(k) number K771199.

Who is the listed applicant for SURGIPULSE HEART RATE MONITOR?

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

What is the FDA product code for SURGIPULSE HEART RATE MONITOR?

The FDA product code for SURGIPULSE HEART RATE MONITOR is 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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