Cleared Traditional

K873361 - LIFE-SPAN CABLE (FDA 510(k) Clearance)

Nov 1987
Decision
80d
Days
Class 2
Risk

K873361 is an FDA 510(k) clearance for the LIFE-SPAN CABLE. This device is classified as a Cable, Electrode (Class II - Special Controls, product code IKD).

Submitted by Chemfet Corp. (Bellevue, US). The FDA issued a Cleared decision on November 9, 1987, 80 days after receiving the submission on August 21, 1987.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1175.

Submission Details

510(k) Number K873361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1987
Decision Date November 09, 1987
Days to Decision 80 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IKD — Cable, Electrode
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.1175