ISCALERT SENSOR SYSTEM
FDA 510(k) clearance K071165 · decided 2007-11-07
Clearance details
- K-number
- K071165
- Device name
- ISCALERT SENSOR SYSTEM
- Applicant
- Alertis Medical AS
- Decision
- Substantially Equivalent
- Date received
- 2007-04-26
- Decision date
- 2007-11-07
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- CCC
- Device class
- 2
- Regulation number
- 868.1150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Findley, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.