FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
K Number: K121382
·
Decision Dec 6, 2012
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
8
Review Days
212
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Basic Information
- Device Name
- WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
- K Number
- K121382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Westmed, Inc.
- Date Received
- May 8, 2012
- Decision Date
- December 6, 2012
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K133057 | VIBRALUNG ACOUSTICAL PERCUSSOR | May 23, 2014 | Substantially Equivalent |
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Jul 15, 2008 | Substantially Equivalent |
| K072220 | PEDI CO2 EASY | Aug 23, 2007 | Substantially Equivalent |
| K070128 | CO2 EASY | Feb 15, 2007 | Substantially Equivalent |
| K953464 | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK | Sep 18, 1995 | Substantially Equivalent |