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FDA 510(k)

PHYSIO-DYNE ECG/HR 3

K-Number: K854847 · 1986-06-16

ApplicantPhysio-Dyne Industrument Corp.
Decision Date1986-06-16
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHYSIO-DYNE ECG/HR 3 is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Dyne Industrument Corp.. It received FDA 510(k) clearance on 1986-06-16 under 510(k) number K854847. 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 PHYSIO-DYNE ECG/HR 3?

PHYSIO-DYNE ECG/HR 3 is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is Physio-Dyne Industrument Corp.. The 510(k) number is K854847.

When did PHYSIO-DYNE ECG/HR 3 receive FDA 510(k) clearance?

PHYSIO-DYNE ECG/HR 3 received FDA 510(k) clearance on 1986-06-16, under 510(k) number K854847.

Who is the listed applicant for PHYSIO-DYNE ECG/HR 3?

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

What is the FDA product code for PHYSIO-DYNE ECG/HR 3?

The FDA product code for PHYSIO-DYNE ECG/HR 3 is DRT.

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Related Devices (Code: DRT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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