The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Calibration Gas For Servo Gas Monitor 120.
| Device ID | K863675 |
| 510k Number | K863675 |
| Device Name: | CALIBRATION GAS FOR SERVO GAS MONITOR 120 |
| Classification | Gas, Calibration (specified Concentration) |
| 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 | BXK |
| CFR Regulation Number | 868.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-19 |
| Decision Date | 1986-11-03 |