FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WESTMED PEDIATRIC AND ADULT AEROSOL MASK
K Number: K945472
·
Decision Feb 7, 1995
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
9
Review Days
91
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Basic Information
- Device Name
- WESTMED PEDIATRIC AND ADULT AEROSOL MASK
- K Number
- K945472
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Westmed Intl.
- Date Received
- November 8, 1994
- Decision Date
- February 7, 1995
- Product Code
- BYG
- 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYG), ordered by most recent decision date.
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WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
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VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
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JEMSDAL MASK
FDA 510(k)
FDA Class 1
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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 |
| K924944 | INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA | Jul 2, 1993 | Substantially Equivalent |
| K925173 | BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT | Jan 15, 1993 | Substantially Equivalent |