Pinwheel

FDA 510(k) K780422 · Projects IN Health

Substantially Equivalent

510(k) numberK780422

Submission

Device name
Pinwheel
Applicant
Projects IN Health
Mchenry, IL, US
Received
March 17, 1978
Decision date
April 4, 1978
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
K871167SensitesterGWY · Traditional Dexin Pty. , Ltd.04/01/1987SE
K8517491-380 Pinwheel (Wartenberg)GWY · Traditional Artiberia06/13/1985SE

More from Artiberia

510(k)DeviceDecision
K781224Meter, Flow, PeakBZH · Traditional 10/15/1978SE
K770580Peak Flow MeterBZH · Traditional 08/04/1977SE

Questions and answers

When was Pinwheel cleared by the FDA?

Pinwheel (K780422) received a 510(k) decision of Substantially Equivalent on April 4, 1978, 18 days after the submission was received.

What is the product code of K780422?

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