FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERVO GUARD, MODEL 64 81 290 EH88E
K Number: K030071
·
Decision Apr 26, 2004
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
1
Review Days
474
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Basic Information
- Device Name
- SERVO GUARD, MODEL 64 81 290 EH88E
- K Number
- K030071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maquet, Inc.
- Date Received
- January 8, 2003
- Decision Date
- April 26, 2004
- 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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