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FDA 510(k)

SENSATRACE

K-Number: K904185 · 1990-10-31

ApplicantLudlow Corp., Technical Papers Division
Decision Date1990-10-31
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSATRACE is the device name listed in this FDA 510(k) record. The listed applicant is Ludlow Corp., Technical Papers Division. It received FDA 510(k) clearance on 1990-10-31 under 510(k) number K904185. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSATRACE?

SENSATRACE is a medical device that received FDA 510(k) clearance on 1990-10-31. The listed applicant is Ludlow Corp., Technical Papers Division. The 510(k) number is K904185.

When did SENSATRACE receive FDA 510(k) clearance?

SENSATRACE received FDA 510(k) clearance on 1990-10-31, under 510(k) number K904185.

Who is the listed applicant for SENSATRACE?

The FDA 510(k) record lists Ludlow Corp., Technical Papers Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSATRACE?

The FDA product code for SENSATRACE is DRX.

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Related Devices (Code: DRX)

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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