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FDA 510(k)

CARDIOSCOPE J200

K-Number: K802179 · 1980-11-12

ApplicantTelectronics, Inc.
Decision Date1980-11-12
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSCOPE J200 is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802179. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSCOPE J200?

CARDIOSCOPE J200 is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Telectronics, Inc.. The 510(k) number is K802179.

When did CARDIOSCOPE J200 receive FDA 510(k) clearance?

CARDIOSCOPE J200 received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802179.

Who is the listed applicant for CARDIOSCOPE J200?

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

What is the FDA product code for CARDIOSCOPE J200?

The FDA product code for CARDIOSCOPE J200 is DRS.

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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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