K871986

Substantially Equivalent

MODEL 5600B PROGRAMMER, PACEMAKER

Applicant
Telectronics, Inc.
Product code
KRG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Suffield, CT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KRG

product code KRG
Malfunction
8,377
Total
8,377

Source: openFDA MAUDE database, through . 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.