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FDA 510(k)

THERATON 1000E

K-Number: K964607 · 1997-05-28

ApplicantTheratronics, Inc.
Decision Date1997-05-28
Product CodeIWD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERATON 1000E is the device name listed in this FDA 510(k) record. The listed applicant is Theratronics, Inc.. It received FDA 510(k) clearance on 1997-05-28 under 510(k) number K964607. The device is classified under product code IWD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERATON 1000E?

THERATON 1000E is a medical device that received FDA 510(k) clearance on 1997-05-28. The listed applicant is Theratronics, Inc.. The 510(k) number is K964607.

When did THERATON 1000E receive FDA 510(k) clearance?

THERATON 1000E received FDA 510(k) clearance on 1997-05-28, under 510(k) number K964607.

Who is the listed applicant for THERATON 1000E?

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 THERATON 1000E?

The FDA product code for THERATON 1000E is IWD.

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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 780EK954679THERAPLAN PLUSK940237THERAPLAN V05B/ TP-11 V09BK922276THERAC 25

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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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