FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
K Number: K043357
·
Decision Mar 4, 2005
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
16
Applicant Total
4
Review Days
88
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Basic Information
- Device Name
- TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
- K Number
- K043357
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2480
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linde Medical Sensors AG
- Date Received
- December 6, 2004
- Decision Date
- March 4, 2005
- Product Code
- LKD
- 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 |
|---|---|---|---|
| LKD | Monitor, Carbon-Dioxide, Cutaneous | FDA class 2 | Anesthesiology |
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