510(k) K934551— VERIFUSE AMBULATORY PUMP

Substantially Equivalent

Block Medical, Inc.

Clearance details

Applicant: Block Medical, Inc.
Product code: Code MEA
Advisory panel: General Hospital
Date received: 1993-09-22
Decision date: 1994-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Adverse events under product code MEA

product code MEA

Death: 19
Malfunction: 25,089
Total: 25,108

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.