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FDA 510(k)

TEXAS BIO SCAN

K-Number: K833694 · 1984-03-02

ApplicantTexas Bio Scan
Decision Date1984-03-02
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TEXAS BIO SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Texas Bio Scan. It received FDA 510(k) clearance on 1984-03-02 under 510(k) number K833694. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEXAS BIO SCAN?

TEXAS BIO SCAN is a medical device that received FDA 510(k) clearance on 1984-03-02. The listed applicant is Texas Bio Scan. The 510(k) number is K833694.

When did TEXAS BIO SCAN receive FDA 510(k) clearance?

TEXAS BIO SCAN received FDA 510(k) clearance on 1984-03-02, under 510(k) number K833694.

Who is the listed applicant for TEXAS BIO SCAN?

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

What is the FDA product code for TEXAS BIO SCAN?

The FDA product code for TEXAS BIO SCAN is HKI.

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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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