FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
M-XX OXYGEN SENSORS
K Number: K002384
·
Decision Dec 15, 2000
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
2
Review Days
133
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Basic Information
- Device Name
- M-XX OXYGEN SENSORS
- K Number
- K002384
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Business Strategies
- Date Received
- August 4, 2000
- Decision Date
- December 15, 2000
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K062149 | SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES | May 31, 2007 | Substantially Equivalent |