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FDA 510(k)

REVISED T-SCAN SYSTEM

K-Number: K870032 · 1987-02-02

ApplicantSentek, Inc.
Decision Date1987-02-02
Product CodeEFH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REVISED T-SCAN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sentek, Inc.. It received FDA 510(k) clearance on 1987-02-02 under 510(k) number K870032. The device is classified under product code EFH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVISED T-SCAN SYSTEM?

REVISED T-SCAN SYSTEM is a medical device that received FDA 510(k) clearance on 1987-02-02. The listed applicant is Sentek, Inc.. The 510(k) number is K870032.

When did REVISED T-SCAN SYSTEM receive FDA 510(k) clearance?

REVISED T-SCAN SYSTEM received FDA 510(k) clearance on 1987-02-02, under 510(k) number K870032.

Who is the listed applicant for REVISED T-SCAN SYSTEM?

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

What is the FDA product code for REVISED T-SCAN SYSTEM?

The FDA product code for REVISED T-SCAN SYSTEM is EFH.

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Related Devices (Code: EFH)

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

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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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