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FDA 510(k)

CONTOUROGRAPH M-500

K-Number: K800591 · 1980-04-02

ApplicantBio-Tek Instruments, Inc.
Decision Date1980-04-02
Product CodeLDK
DecisionSubstantially Equivalent

Device Summary

CONTOUROGRAPH M-500 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1980-04-02 under 510(k) number K800591. The device is classified under product code LDK. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTOUROGRAPH M-500?

CONTOUROGRAPH M-500 is a medical device that received FDA 510(k) clearance on 1980-04-02. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K800591.

When did CONTOUROGRAPH M-500 receive FDA 510(k) clearance?

CONTOUROGRAPH M-500 received FDA 510(k) clearance on 1980-04-02, under 510(k) number K800591.

Who is the listed applicant for CONTOUROGRAPH M-500?

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

What is the FDA product code for CONTOUROGRAPH M-500?

The FDA product code for CONTOUROGRAPH M-500 is LDK.

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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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