THD Slide

FDA 510(k) K081429 · Thd Spa

Substantially Equivalent

510(k) numberK081429

Submission

Device name
THD Slide
Applicant
Thd Spa
North Reading, MA, US
Received
May 21, 2008
Decision date
July 30, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAF – Monitor, Ultrasonic, Nonfetal
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1540
Specialty
Radiology

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Questions and answers

When was THD Slide cleared by the FDA?

THD Slide (K081429) received a 510(k) decision of Substantially Equivalent on July 30, 2008, 70 days after the submission was received.

What is the product code of K081429?

The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.