TCD or TCD Neuropathy Star

FDA 510(k) K944234 · Jcm Management & Planning Co.

Substantially Equivalent

510(k) numberK944234

Submission

Device name
TCD or TCD Neuropathy Star
Applicant
Jcm Management & Planning Co.
Wilmington, DE, US
Received
August 31, 1994
Decision date
March 8, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GWI – Discriminator, Two-Point
Device class
Class I (low risk)
Regulation
21 CFR 882.1200
Specialty
Neurology

Other 510(k)s with product code GWI

510(k)DeviceApplicantDecision
K874300AesthesiometerGWI · Traditional Orthopedic Systems, Inc.11/06/1987SE

Questions and answers

When was TCD or TCD Neuropathy Star cleared by the FDA?

TCD or TCD Neuropathy Star (K944234) received a 510(k) decision of Substantially Equivalent on March 8, 1995, 189 days after the submission was received.

What is the product code of K944234?

The FDA product code is GWI – Discriminator, Two-Point, a Class I (low risk) device regulated under 21 CFR 882.1200.