Cleared Traditional

K972043 - MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER (FDA 510(k) Clearance)

K972043 · Medtronic Vascular · Neurology device

Aug 1997

Decision

81d

Days

Class 2

Risk

K972043 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER. This device is classified as a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II - Special Controls, product code GZB).

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 22, 1997, 81 days after receiving the submission on June 2, 1997.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.

Submission Details

510(k) Number	K972043 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 02, 1997
Decision Date	August 22, 1997
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GZB — Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 882.5880