SERVO VENTILATOR 300A
FDA 510(k) clearance K970839 · decided 1997-10-14
Clearance details
- K-number
- K970839
- Device name
- SERVO VENTILATOR 300A
- Applicant
- Siemens Elema AB
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1997-03-07
- Decision date
- 1997-10-14
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- S-17195 Solna, SE
- Third-party review
- No
- Expedited review
- No
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