NPB-4000— 510(k) K962424

Substantially Equivalent

Analogic Corp.

FDA 510(k) clearance K962424 for NPB-4000, Substantially Equivalent on 1996-12-20. Applicant: Analogic Corp..

Clearance details

Applicant: Analogic Corp.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 1996-06-24
Decision date: 1996-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peabody, MA, US

Download summary PDF View on FDA.gov ↗

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.