Cleared Traditional

K920436 - MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR (FDA 510(k) Clearance)

K920436 · Medtronic Vascular · Physical Medicine device

May 1992

Decision

107d

Days

Class 2

Risk

K920436 is an FDA 510(k) clearance for the MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 20, 1992, 107 days after receiving the submission on February 3, 1992.

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

Submission Details

510(k) Number	K920436 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 03, 1992
Decision Date	May 20, 1992
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement