The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Servo Ventilator 300a.
| Device ID | K970839 |
| 510k Number | K970839 |
| Device Name: | SERVO VENTILATOR 300A |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | SIEMENS ELEMA AB RONTGENVAGEN 2 S-17195 Solna, SE |
| Contact | Ann-christine Jonsson |
| Correspondent | Ann-christine Jonsson SIEMENS ELEMA AB RONTGENVAGEN 2 S-17195 Solna, SE |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-10-14 |
| Summary: | summary |