Cleared Traditional

K953652 - PRENVAL I
(FDA 510(k) Clearance)

K953652 · Base Ten Systems, Inc. · Immunology

Sep 1995

Decision

39d

Days

Class 1

Risk

K953652 is an FDA 510(k) clearance for the PRENVAL I, a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP), submitted by Base Ten Systems, Inc. (Trenton, US). The FDA issued a Cleared decision on September 15, 1995, 39 days after receiving the submission on August 7, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number	K953652 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 1995
Decision Date	September 15, 1995
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement