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FDA 510(k)

MODEL 8300 TESTER

K-Number: K823197 · 1982-12-30

ApplicantMedicon, Inc.
Decision Date1982-12-30
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 8300 TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Medicon, Inc.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823197. 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 MODEL 8300 TESTER?

MODEL 8300 TESTER is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Medicon, Inc.. The 510(k) number is K823197.

When did MODEL 8300 TESTER receive FDA 510(k) clearance?

MODEL 8300 TESTER received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823197.

Who is the listed applicant for MODEL 8300 TESTER?

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

What is the FDA product code for MODEL 8300 TESTER?

The FDA product code for MODEL 8300 TESTER is DRT.

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Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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