Cleared Traditional

MODEL 5650 OPTIMATE PERSONAL PROGRAMMER

K884522 · Teletronics, Inc. · Cardiovascular

Aug 1989

Decision

302d

Days

Class 3

Risk

About This 510(k) Submission

K884522 is an FDA 510(k) clearance for the MODEL 5650 OPTIMATE PERSONAL PROGRAMMER, a Programmer, Pacemaker (Class III — Premarket Approval, product code KRG), submitted by Teletronics, Inc. (Suffield, US). The FDA issued a Cleared decision on August 25, 1989, 302 days after receiving the submission on October 27, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.

Submission Details

510(k) Number	K884522 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 1988
Decision Date	August 25, 1989
Days to Decision	302 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—