MOBILE-PATIENT VIEWER— 510(k) K011436

Name: FDA 510(k) clearance K011436
Creator: U.S. Food and Drug Administration
Published: 2001-07-05

Substantially Equivalent

Data Critical Corporation

FDA 510(k) clearance K011436 for MOBILE-PATIENT VIEWER, Substantially Equivalent on 2001-07-05. Applicant: Data Critical Corporation. Device class: 2.

Clearance details

Applicant: Data Critical Corporation
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2001-05-10
Decision date: 2001-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.