DeviceClearance

OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM— 510(k) K950688

Substantially Equivalent

Safety Tek Corp.

FDA 510(k) clearance K950688 for OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM, Substantially Equivalent on 1996-04-18. Applicant: Safety Tek Corp.. Device class: 2.

Clearance details

Applicant
Safety Tek Corp.
Product code
Code DRT
Device class
Class 2
Regulation
21 CFR 870.2300
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Orlando, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DRT

product code DRT
Death
4
Total
4

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.