FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL
K Number: K912753
·
Decision Sep 23, 1991
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
12
Review Days
91
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Basic Information
- Device Name
- XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL
- K Number
- K912753
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Xomed-Treace, Inc.
- Date Received
- June 24, 1991
- Decision Date
- September 23, 1991
- Product Code
- GCX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | FDA class 2 | General Hospital |
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Other Clearances by Xomed-Treace, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940028 | ENDOSCOPE SHEATH | Mar 24, 1995 | Substantially Equivalent |
| K941407 | TYMPANOSTOMY (VENTILATION) TUBE | Mar 14, 1995 | Substantially Equivalent |
| K945659 | BLACKSTAR(TM) STAR SYSTEM | Jan 9, 1995 | Substantially Equivalent |
| K932771 | BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE | Aug 24, 1994 | Substantially Equivalent |
| K933672 | XOMED-TREACE SCOPESHEATH | Jul 18, 1994 | Substantially Equivalent |
| K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | May 13, 1994 | Substantially Equivalent |
| K933105 | XOMED-TREACE RIGID ROD LENS ENDOSCOPE | Jan 5, 1994 | Substantially Equivalent |
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | Aug 17, 1993 | Substantially Equivalent |
| K922880 | XOMED TREACE JET VENTILATION TUBE | Apr 15, 1993 | Substantially Equivalent |
| K923830 | XOMED-TREACE ALPHASCOPE | Nov 9, 1992 | Substantially Equivalent |