Cleared Traditional

THERAPY CASSETTS

K854920 · Alpha Therapeutic Corp. · Cardiovascular
May 1986
Decision
160d
Days
Risk

About This 510(k) Submission

K854920 is an FDA 510(k) clearance for the THERAPY CASSETTS, submitted by Alpha Therapeutic Corp. (Rouses Point, US). The FDA issued a Cleared decision on May 19, 1986, 160 days after receiving the submission on December 10, 1985. This device falls under the Cardiovascular review panel.

Submission Details

510(k) Number K854920 FDA.gov
FDA Decision Cleared SN
Date Received December 10, 1985
Decision Date May 19, 1986
Days to Decision 160 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code MCU
Device Class