(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH— 510(k) K962473
Substantially Equivalent - Subject to Tracking Reg.Data Critical Corporation
FDA 510(k) clearance K962473 for (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH, Substantially Equivalent - Subject to Tracking Reg. on 1997-11-06. Applicant: Data Critical Corporation.
Clearance details
- Applicant
- Data Critical Corporation
- Product code
- Code MSX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Adverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
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.