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FDA 510(k)

THERAVIEW

K-Number: K960510 · 1996-04-22

ApplicantInfimed, Inc.
Decision Date1996-04-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERAVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Infimed, Inc.. It received FDA 510(k) clearance on 1996-04-22 under 510(k) number K960510. 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 THERAVIEW?

THERAVIEW is a medical device that received FDA 510(k) clearance on 1996-04-22. The listed applicant is Infimed, Inc.. The 510(k) number is K960510.

When did THERAVIEW receive FDA 510(k) clearance?

THERAVIEW received FDA 510(k) clearance on 1996-04-22, under 510(k) number K960510.

Who is the listed applicant for THERAVIEW?

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

What is the FDA product code for THERAVIEW?

The FDA product code for THERAVIEW is 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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