FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXICHECK
K Number: K023565
·
Decision Mar 28, 2003
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
5
Review Days
156
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Basic Information
- Device Name
- OXICHECK
- K Number
- K023565
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Caradyne, Ltd.
- Date Received
- October 23, 2002
- Decision Date
- March 28, 2003
- 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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Other Clearances by Caradyne, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K040862 | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM | Jun 30, 2004 | Substantially Equivalent |
| K000959 | CRITERION 60 OR PM 60 | Jun 22, 2000 | Substantially Equivalent |
| K992101 | CRITERION 40 OR PM 40 | Jan 6, 2000 | Substantially Equivalent |
| K982283 | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH | Mar 9, 1999 | Substantially Equivalent |