FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM 22 VALVE
K Number: K950397
·
Decision Apr 14, 1995
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
26
Review Days
72
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Basic Information
- Device Name
- SYSTEM 22 VALVE
- K Number
- K950397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Turnkey Intergration USA, Inc.
- Date Received
- February 1, 1995
- Decision Date
- April 14, 1995
- Product Code
- BYE
- 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 |
|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K972411 | LINK CEMENT PLUG | Aug 29, 1997 | Substantially Equivalent |
| K970284 | ARTOS, DIPLOS SYSTEM | Apr 21, 1997 | Substantially Equivalent |
| K970084 | LINK CERCLAGE WIRE SYSTEM | Mar 13, 1997 | Substantially Equivalent |
| K953653 | LUBINUS SP II HIP SYSTEM | Nov 6, 1995 | Substantially Equivalent |
| K943986 | LINK ENDO MODEL REVISION CUP | Jul 5, 1995 | Substantially Equivalent |
| K951355 | LINK SADDLE PROTHESIS | May 25, 1995 | Substantially Equivalent |
| K940297 | UNIVERSAL WRIST | Feb 6, 1995 | Substantially Equivalent for Some Indications |