FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
XOMED-TREACE ALPHASCOPE
K Number: K923830
·
Decision Nov 9, 1992
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
55
Applicant Total
12
Review Days
101
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Basic Information
- Device Name
- XOMED-TREACE ALPHASCOPE
- K Number
- K923830
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4770
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xomed-Treace, Inc.
- Date Received
- July 31, 1992
- Decision Date
- November 9, 1992
- Product Code
- ERA
- 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 |
|---|---|---|---|
| ERA | Otoscope | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ERA), ordered by most recent decision date.
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OSRAM ITOS
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OPTUS OTOSCOPES
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FDA Class 1
·Ear, Nose, Throat
WELCH ALLYN BI-OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
WELCH ALLY OTOSCOPE
FDA 510(k)
FDA Class 1
·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 |
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | Aug 17, 1993 | Substantially Equivalent |
| K922880 | XOMED TREACE JET VENTILATION TUBE | Apr 15, 1993 | Substantially Equivalent |
| K912753 | XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL | Sep 23, 1991 | Substantially Equivalent |