The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Servo Nebulizer 945 Siemens-elema Ab.
| Device ID | K871293 |
| 510k Number | K871293 |
| Device Name: | SERVO NEBULIZER 945 SIEMENS-ELEMA AB |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
| Contact | Ellen Farney |
| Correspondent | Ellen Farney SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-31 |
| Decision Date | 1987-05-08 |