The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Connection Cable For Synchronization Of Two Servo.
Device ID | K850374 |
510k Number | K850374 |
Device Name: | CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO |
Classification | Ventilator, Continuous, Facility Use |
Applicant | SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
Contact | Christer Hellsten |
Correspondent | Christer Hellsten SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-31 |
Decision Date | 1985-04-25 |