FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TWINGUARD WITH CAPNOGRAPH ACCESSORY
K Number: K080527
·
Decision Oct 31, 2008
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
301
Applicant Total
1
Review Days
248
Basic Information
- Device Name
- TWINGUARD WITH CAPNOGRAPH ACCESSORY
- K Number
- K080527
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TRAWAX PTY LIMITED
- Date Received
- February 26, 2008
- Decision Date
- October 31, 2008
- Product Code
- CCK
- 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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