FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRAMAXO2 OXYGEN ANALYER
K Number: K112402
·
Decision Dec 14, 2011
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
6
Review Days
114
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Basic Information
- Device Name
- ULTRAMAXO2 OXYGEN ANALYER
- K Number
- K112402
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxtec, LLC
- Date Received
- August 22, 2011
- Decision Date
- December 14, 2011
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
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