FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA
K Number: K924944
·
Decision Jul 2, 1993
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
9
Review Days
275
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Basic Information
- Device Name
- INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA
- K Number
- K924944
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Westmed Intl.
- Date Received
- September 30, 1992
- Decision Date
- July 2, 1993
- Product Code
- EMX
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Westmed Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K955047 | WESTMED CIRCULARIE PEP DEVICES | Mar 27, 1996 | Substantially Equivalent |
| K954271 | WESTMED CONDESATE COLLECTION TRAP | Dec 28, 1995 | Substantially Equivalent |
| K952616 | MICROTIME | Sep 27, 1995 | Substantially Equivalent |
| K953687 | WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER | Sep 18, 1995 | Substantially Equivalent |
| K953506 | WESTMED RESPIRATORY LUER ADAPTOR | Sep 15, 1995 | Substantially Equivalent |
| K951484 | WESTMED BACTERIAL/VIRAL FILTER | Apr 24, 1995 | Substantially Equivalent |
| K945472 | WESTMED PEDIATRIC AND ADULT AEROSOL MASK | Feb 7, 1995 | Substantially Equivalent |
| K925173 | BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT | Jan 15, 1993 | Substantially Equivalent |