K091548

Substantially Equivalent

AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A

Applicant: Amco International Manufacturing & Design, Inc.
Product code: MKJ
Advisory panel: Cardiovascular
Date received: 2009-05-27
Decision date: 2009-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elizabeth, CO, US

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.