Cleared Traditional

K860164 - 2500 PRINTER (FDA 510(k) Clearance)

K860164 · Datascope Corp. · Cardiovascular device
Jun 1986
Decision
139d
Days
-
Risk

K860164 is an FDA 510(k) clearance for the 2500 PRINTER..

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on June 5, 1986, 139 days after receiving the submission on January 17, 1986.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number K860164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1986
Decision Date June 05, 1986
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -

Device Classification

Product Code -
Device Class -