FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WESTMED RESPIRATORY LUER ADAPTOR
K Number: K953506
·
Decision Sep 15, 1995
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
6
Applicant Total
9
Review Days
51
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Basic Information
- Device Name
- WESTMED RESPIRATORY LUER ADAPTOR
- K Number
- K953506
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2350
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Westmed Intl.
- Date Received
- July 26, 1995
- Decision Date
- September 15, 1995
- Product Code
- BXY
- 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 |
|---|---|---|---|
| BXY | Flowmeter, Calibration, Gas | FDA class 1 | Anesthesiology |
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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 |
| K951484 | WESTMED BACTERIAL/VIRAL FILTER | Apr 24, 1995 | Substantially Equivalent |
| K945472 | WESTMED PEDIATRIC AND ADULT AEROSOL MASK | Feb 7, 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 |