The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Lung Mechanics Software Program.
| Device ID | K864105 |
| 510k Number | K864105 |
| Device Name: | LUNG MECHANICS SOFTWARE PROGRAM |
| 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 | 1986-10-21 |
| Decision Date | 1986-11-07 |