MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
FDA 510(k) clearance K041223 · decided 2004-07-29
Clearance details
- K-number
- K041223
- Device name
- MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
- Applicant
- Maquet Critical Care AB
- Decision
- Substantially Equivalent
- Date received
- 2004-05-10
- Decision date
- 2004-07-29
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bridgewater, NJ, US
- Third-party review
- No
- Expedited review
- No
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