FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
K Number: K925640
·
Decision Aug 17, 1993
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
96
Applicant Total
12
Review Days
281
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
- K Number
- K925640
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xomed-Treace, Inc.
- Date Received
- November 9, 1992
- Decision Date
- August 17, 1993
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETN), ordered by most recent decision date.
Evala Nerve Stimulator (EPNR002)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Bioscope Neuromonitor Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EARP Nerve Cuff Electrode
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Disposable Laryngeal Electrodes
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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 |
| K922880 | XOMED TREACE JET VENTILATION TUBE | Apr 15, 1993 | Substantially Equivalent |
| K923830 | XOMED-TREACE ALPHASCOPE | Nov 9, 1992 | Substantially Equivalent |
| K912753 | XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL | Sep 23, 1991 | Substantially Equivalent |