Regain Desktop

FDA 510(k) K003127 · Srs Medical Systems, Inc.

Substantially Equivalent

510(k) numberK003127

Submission

Device name
Regain Desktop
Applicant
Srs Medical Systems, Inc.
Redmond, WA, US
Received
October 6, 2000
Decision date
January 4, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was Regain Desktop cleared by the FDA?

Regain Desktop (K003127) received a 510(k) decision of Substantially Equivalent on January 4, 2001, 90 days after the submission was received.

What is the product code of K003127?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.