FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRITERION 40 OR PM 40
K Number: K992101
·
Decision Jan 6, 2000
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
5
Review Days
198
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Basic Information
- Device Name
- CRITERION 40 OR PM 40
- K Number
- K992101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Caradyne, Ltd.
- Date Received
- June 22, 1999
- Decision Date
- January 6, 2000
- Product Code
- CAP
- 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 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 |
| K023565 | OXICHECK | Mar 28, 2003 | Substantially Equivalent |
| K000959 | CRITERION 60 OR PM 60 | Jun 22, 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 |