MOBILECARE MONITOR— 510(k) K122333

Name: FDA 510(k) clearance K122333
Creator: U.S. Food and Drug Administration
Published: 2012-11-19

Substantially Equivalent

Aframe Digital, Inc.

FDA 510(k) clearance K122333 for MOBILECARE MONITOR, Substantially Equivalent on 2012-11-19. Applicant: Aframe Digital, Inc..

Clearance details

Applicant: Aframe Digital, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2012-08-02
Decision date: 2012-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reston, VA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.