ESCORT PORTABLE PATIENT MONITOR— 510(k) K872291

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K872291 for ESCORT PORTABLE PATIENT MONITOR, Substantially Equivalent on 1987-09-25. Applicant: Medical Data Electronics. Device class: 2.

Clearance details

Applicant
Medical Data Electronics
Product code
Code DXO
Device class
Class 2
Regulation
21 CFR 870.2870
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arleta, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DXO

product code DXO
Death
10
Injury
156
Malfunction
884
Total
1,050

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.