The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Servo Gas Monitor 120.
Device ID | K861625 |
510k Number | K861625 |
Device Name: | SERVO GAS MONITOR 120 |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
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 | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-29 |
Decision Date | 1986-05-02 |