Caretaker Remote Display App and Caretaker Software Library— 510(k) K181196

Substantially Equivalent

Caretaker Medical, LLC

FDA 510(k) clearance K181196 for Caretaker Remote Display App and Caretaker Software Library, Substantially Equivalent on 2018-10-03. Applicant: Caretaker Medical, LLC.

Clearance details

Applicant
Caretaker Medical, LLC
Product code
Code DRG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Charlottesville, VA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DRG

product code DRG
Death
5
Total
5

Source: openFDA MAUDE database, through . 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.