The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Servo Ventilator 300 Computer Interface.
| Device ID | K960010 |
| 510k Number | K960010 |
| Device Name: | SERVO VENTILATOR 300 COMPUTER INTERFACE |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | SIEMENS ELEMA AB 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Steven Clarke |
| Correspondent | Steven Clarke SIEMENS ELEMA AB 49 PLAIN ST. North Attleboro, MA 02760 |
| 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 | 1996-01-02 |
| Decision Date | 1996-10-25 |
| Summary: | summary |