ISCALERT SENSOR SYSTEM— 510(k) K071165
Substantially EquivalentAlertis Medical AS
FDA 510(k) clearance K071165 for ISCALERT SENSOR SYSTEM, Substantially Equivalent on 2007-11-07. Applicant: Alertis Medical AS. Device class: 2.
Clearance details
- Applicant
- Alertis Medical AS
- Product code
- Code CCC
- Device class
- Class 2
- Regulation
- 21 CFR 868.1150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Findley, MN, US
Recent devices under product code CCC
view all- K983198 — TRENDCARE CALIBRATOR MODEL SCU 7007
- K972314 — PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM
- K953893 — PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
- K961790 — POINT-OF-CARE BLOOD GAS MONITOR SYSTEM
- K963935 — OLYMPUS CRITICAL CARE MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.