MICROPAQ, MODELS 402 AND 404— 510(k) K002725

Substantially Equivalent

Protocol Systems, Inc.

FDA 510(k) clearance K002725 for MICROPAQ, MODELS 402 AND 404, Substantially Equivalent on 2000-11-21. Applicant: Protocol Systems, Inc..

Clearance details

Applicant: Protocol Systems, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2000-08-31
Decision date: 2000-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.