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FDA 510(k)

TLC PEDIATRIC FRAME, MODEL TLC-SYS

K-Number: K991523 · 1999-07-30

ApplicantRadionics, Inc.
Decision Date1999-07-30
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TLC PEDIATRIC FRAME, MODEL TLC-SYS is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K991523. 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 TLC PEDIATRIC FRAME, MODEL TLC-SYS?

TLC PEDIATRIC FRAME, MODEL TLC-SYS is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Radionics, Inc.. The 510(k) number is K991523.

When did TLC PEDIATRIC FRAME, MODEL TLC-SYS receive FDA 510(k) clearance?

TLC PEDIATRIC FRAME, MODEL TLC-SYS received FDA 510(k) clearance on 1999-07-30, under 510(k) number K991523.

Who is the listed applicant for TLC PEDIATRIC FRAME, MODEL TLC-SYS?

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

What is the FDA product code for TLC PEDIATRIC FRAME, MODEL TLC-SYS?

The FDA product code for TLC PEDIATRIC FRAME, MODEL TLC-SYS 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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