Resperate; Model RR-150

FDA 510(k) K020399 · Intercure , Ltd.

Substantially Equivalent

510(k) numberK020399

Submission

Device name
Resperate; Model RR-150
Applicant
Intercure , Ltd.
Washington, DC, US
Received
February 6, 2002
Decision date
July 2, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Resperate; Model RR-150 cleared by the FDA?

Resperate; Model RR-150 (K020399) received a 510(k) decision of Substantially Equivalent on July 2, 2002, 146 days after the submission was received.

What is the product code of K020399?

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