MODEL 5650 OPTIMATE PERSONAL PROGRAMMER— 510(k) K884522

Substantially Equivalent

Teletronics, Inc.

FDA 510(k) clearance K884522 for MODEL 5650 OPTIMATE PERSONAL PROGRAMMER, Substantially Equivalent on 1989-08-25. Applicant: Teletronics, Inc..

Clearance details

Applicant: Teletronics, Inc.
Product code: Code KRG
Advisory panel: Cardiovascular
Date received: 1988-10-27
Decision date: 1989-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suffield, CT, US

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Adverse events under product code KRG

product code KRG

Malfunction: 8,377
Total: 8,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.