SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
FDA 510(k) clearance K040221 · decided 2004-02-20
Clearance details
- K-number
- K040221
- Device name
- SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
- Applicant
- Maquet Critical Care AB
- Decision
- Substantially Equivalent
- Date received
- 2004-02-02
- Decision date
- 2004-02-20
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Maquet Critical Care AB
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Servo-i Ventilator recall (Z-0878-05) | Maquet Inc | 2005-06-08 |