FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
FLEXICARE BREATHING FILTERS
K Number: K092218
·
Decision Oct 6, 2009
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
7
Review Days
76
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Basic Information
- Device Name
- FLEXICARE BREATHING FILTERS
- K Number
- K092218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Flexicare Medical, Ltd.
- Date Received
- July 22, 2009
- Decision Date
- October 6, 2009
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- Third Party
- Y
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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| K Number | Device Name | ||
|---|---|---|---|
| K150900 | Flexicare Heated Wire Breathing Systems | May 15, 2015 | Substantially Equivalent |
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| K140113 | O2 NASAL CANNULA WITH CO2 MONITORING | Mar 6, 2014 | Substantially Equivalent |
| K132619 | CLASSIC INTERMITTENT CATHETER | Oct 11, 2013 | Substantially Equivalent |
| K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | Jun 17, 2009 | Substantially Equivalent |
| K951652 | VENTIMASK MK IV | Apr 27, 1995 | Substantially Equivalent |