Cleared Traditional

K823279 - RESPOND QUADRIFLEX #3129 SINGLE CHANNEL (FDA 510(k) Clearance)

K823279 · Medtronic Vascular · Physical Medicine device

Nov 1982

Decision

19d

Days

Class 2

Risk

K823279 is an FDA 510(k) clearance for the RESPOND QUADRIFLEX #3129 SINGLE CHANNEL. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on November 22, 1982, 19 days after receiving the submission on November 3, 1982.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K823279 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 03, 1982
Decision Date	November 22, 1982
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—