FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
K Number: K001095
·
Decision Jun 30, 2000
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
3
Review Days
87
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Basic Information
- Device Name
- OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
- K Number
- K001095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teledyne Analytical Instruments
- Date Received
- April 4, 2000
- Decision Date
- June 30, 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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