BATTERY PACKS FOR CARDIOVASCULAR UNITS— 510(k) K881643

Substantially Equivalent

Dowit Service Co., Inc.

FDA 510(k) clearance K881643 for BATTERY PACKS FOR CARDIOVASCULAR UNITS, Substantially Equivalent on 1988-05-17. Applicant: Dowit Service Co., Inc..

Clearance details

Applicant: Dowit Service Co., Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 1988-04-04
Decision date: 1988-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Towaco, NJ, US

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.