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FDA 510(k)

SENSOR SHEATH TS1

K-Number: K962386 · 1996-08-20

ApplicantRadiotherapeutics Corp.
Decision Date1996-08-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SENSOR SHEATH TS1 is the device name listed in this FDA 510(k) record. The listed applicant is Radiotherapeutics Corp.. It received FDA 510(k) clearance on 1996-08-20 under 510(k) number K962386. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSOR SHEATH TS1?

SENSOR SHEATH TS1 is a medical device that received FDA 510(k) clearance on 1996-08-20. The listed applicant is Radiotherapeutics Corp.. The 510(k) number is K962386.

When did SENSOR SHEATH TS1 receive FDA 510(k) clearance?

SENSOR SHEATH TS1 received FDA 510(k) clearance on 1996-08-20, under 510(k) number K962386.

Who is the listed applicant for SENSOR SHEATH TS1?

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

What is the FDA product code for SENSOR SHEATH TS1?

The FDA product code for SENSOR SHEATH TS1 is FLL.

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Related Devices (Code: FLL)

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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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