FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XOMED TREACE JET VENTILATION TUBE
K Number: K922880
·
Decision Apr 15, 1993
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
12
Review Days
304
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Basic Information
- Device Name
- XOMED TREACE JET VENTILATION TUBE
- K Number
- K922880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xomed-Treace, Inc.
- Date Received
- June 15, 1992
- Decision Date
- April 15, 1993
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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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 |
| K923830 | XOMED-TREACE ALPHASCOPE | Nov 9, 1992 | Substantially Equivalent |
| K912753 | XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL | Sep 23, 1991 | Substantially Equivalent |