Cleared Traditional

SUPPORT ARM

K854162 · Healthmate, Inc. · General & Plastic Surgery
Dec 1985
Decision
55d
Days
Risk

About This 510(k) Submission

K854162 is an FDA 510(k) clearance for the SUPPORT ARM, submitted by Healthmate, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 9, 1985, 55 days after receiving the submission on October 15, 1985. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K854162 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1985
Decision Date December 09, 1985
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class