Sensitester

FDA 510(k) K871167 · Dexin Pty. , Ltd.

Substantially Equivalent

510(k) numberK871167

Submission

Device name
Sensitester
Applicant
Dexin Pty. , Ltd.
Western Australia, AU
Received
March 24, 1987
Decision date
April 1, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GWY – Pinwheel
Device class
Class I (low risk)
Regulation
21 CFR 882.1750
Specialty
Neurology

Other 510(k)s with product code GWY

510(k)DeviceApplicantDecision
K050313Bis SRS (Semi-Resuable Sensor)GWY · Traditional Aspect Medical Systems, Inc.02/24/2005SE
K942926Neuro-AideGWY · Traditional Burke Neutech, Inc.08/03/1994SE
K8517491-380 Pinwheel (Wartenberg)GWY · Traditional Artiberia06/13/1985SE
K780422PinwheelGWY · Traditional Projects IN Health04/04/1978SE

Questions and answers

When was Sensitester cleared by the FDA?

Sensitester (K871167) received a 510(k) decision of Substantially Equivalent on April 1, 1987, 8 days after the submission was received.

What is the product code of K871167?

The FDA product code is GWY – Pinwheel, a Class I (low risk) device regulated under 21 CFR 882.1750.