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FDA 510(k)

THERAPLAN V05B/ TP-11 V09B

K-Number: K940237 · 1994-07-26

ApplicantTheratronics, Inc.
Decision Date1994-07-26
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERAPLAN V05B/ TP-11 V09B is the device name listed in this FDA 510(k) record. The listed applicant is Theratronics, Inc.. It received FDA 510(k) clearance on 1994-07-26 under 510(k) number K940237. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPLAN V05B/ TP-11 V09B?

THERAPLAN V05B/ TP-11 V09B is a medical device that received FDA 510(k) clearance on 1994-07-26. The listed applicant is Theratronics, Inc.. The 510(k) number is K940237.

When did THERAPLAN V05B/ TP-11 V09B receive FDA 510(k) clearance?

THERAPLAN V05B/ TP-11 V09B received FDA 510(k) clearance on 1994-07-26, under 510(k) number K940237.

Who is the listed applicant for THERAPLAN V05B/ TP-11 V09B?

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

What is the FDA product code for THERAPLAN V05B/ TP-11 V09B?

The FDA product code for THERAPLAN V05B/ TP-11 V09B is IYE.

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Other records listing Theratronics, Inc. as applicant

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.

K983917THERATRON ELITEK970236THERAPLAN PLUS VERSION 1.2K964606THERATRON 780EK964607THERATON 1000EK954679THERAPLAN PLUSK922276THERAC 25

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Related Devices (Code: IYE)

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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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