KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
FDA 510(k) clearance K010923 · decided 2002-01-23
Clearance details
- K-number
- K010923
- Device name
- KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
- Applicant
- Siemens Elema AB
- Decision
- Substantially Equivalent
- Date received
- 2001-03-27
- Decision date
- 2002-01-23
- Days to decision
- 302 days
- Clearance type
- Abbreviated
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.