FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NERVE INTEGRITY MONITOR-2 (NIM-2 XL)
K Number: K934426
·
Decision May 13, 1994
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
96
Applicant Total
12
Review Days
245
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Basic Information
- Device Name
- NERVE INTEGRITY MONITOR-2 (NIM-2 XL)
- K Number
- K934426
- 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
- September 10, 1993
- Decision Date
- May 13, 1994
- 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
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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 |
| 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 |
| K912753 | XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL | Sep 23, 1991 | Substantially Equivalent |