DeviceClearance

VITALERT 1000 MONITORING SYSTEM— 510(k) K873380

Substantially Equivalent

Draeger Medical, Inc.

FDA 510(k) clearance K873380 for VITALERT 1000 MONITORING SYSTEM, Substantially Equivalent on 1988-04-14. Applicant: Draeger Medical, Inc..

Clearance details

Applicant
Draeger Medical, Inc.
Product code
Code CCK
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Telford, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

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.