FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.
K Number: K831427
·
Decision Jul 7, 1983
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
9
Review Days
65
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Basic Information
- Device Name
- CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.
- K Number
- K831427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Fraser Harlake, Inc.
- Date Received
- May 3, 1983
- Decision Date
- July 7, 1983
- Product Code
- CAD
- 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | FDA class 2 | Anesthesiology |
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Other Clearances by Fraser Harlake, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841903 | FRASER HARLAKE EMERG. CARE SUCTION SYS | Jun 14, 1984 | Substantially Equivalent |
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| K841496 | FRASER HARLAKE HOPE III RESUSCITATOR | Apr 24, 1984 | Substantially Equivalent |
| K833692 | FRASER HARLAKE DENTAL ANTI-POLUTION SYS | Nov 29, 1983 | Substantially Equivalent |
| K833151 | BOYLE SYSTEM ANESTHESIA GAS MACHINE | Nov 14, 1983 | Substantially Equivalent |
| K822040 | POWERED EMERGENCY VENTILATOR | Aug 19, 1982 | Substantially Equivalent |
| K821744 | FRASER HARLAKE NITRONOX SCAVENGER | Jun 25, 1982 | Substantially Equivalent |
| K802943 | POSITIVE END EXPIRATORY PRESSURE VALVE | Jan 15, 1981 | Substantially Equivalent |