ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002— 510(k) K964515

Substantially Equivalent

M.C. Healthcare Products, Inc.

FDA 510(k) clearance K964515 for ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002, Substantially Equivalent on 1996-12-31. Applicant: M.C. Healthcare Products, Inc..

Clearance details

Applicant: M.C. Healthcare Products, Inc.
Product code: Code FNL
Advisory panel: General Hospital
Date received: 1996-10-16
Decision date: 1996-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beamsville, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FNL

product code FNL

Death: 64
Injury: 728
Malfunction: 10,825
Other: 9
Total: 11,626

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.