FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
K Number: K072002
·
Decision Jan 31, 2008
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
10
Review Days
192
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Basic Information
- Device Name
- FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
- K Number
- K072002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Draeger Medical AG & Co. KG
- Date Received
- July 23, 2007
- Decision Date
- January 31, 2008
- 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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