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FDA 510(k)

THERAPLAN PLUS VERSION 1.2

K-Number: K970236 · 1997-07-09

ApplicantTheratronics, Inc.
Decision Date1997-07-09
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERAPLAN PLUS VERSION 1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Theratronics, Inc.. It received FDA 510(k) clearance on 1997-07-09 under 510(k) number K970236. 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 PLUS VERSION 1.2?

THERAPLAN PLUS VERSION 1.2 is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is Theratronics, Inc.. The 510(k) number is K970236.

When did THERAPLAN PLUS VERSION 1.2 receive FDA 510(k) clearance?

THERAPLAN PLUS VERSION 1.2 received FDA 510(k) clearance on 1997-07-09, under 510(k) number K970236.

Who is the listed applicant for THERAPLAN PLUS VERSION 1.2?

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 PLUS VERSION 1.2?

The FDA product code for THERAPLAN PLUS VERSION 1.2 is IYE.

Related Clinical Trials

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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 ELITEK964606THERATRON 780EK964607THERATON 1000EK954679THERAPLAN PLUSK940237THERAPLAN V05B/ TP-11 V09BK922276THERAC 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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