FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISCALERT SENSOR SYSTEM
K Number: K071165
·
Decision Nov 7, 2007
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
14
Applicant Total
1
Review Days
195
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Basic Information
- Device Name
- ISCALERT SENSOR SYSTEM
- K Number
- K071165
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alertis Medical AS
- Date Received
- April 26, 2007
- Decision Date
- November 7, 2007
- Product Code
- CCC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | FDA class 2 | Anesthesiology |
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