The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Servo Humidifier 152 Siemens-elema Ab.
| Device ID | K844040 |
| 510k Number | K844040 |
| Device Name: | SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| 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 | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-16 |
| Decision Date | 1984-10-25 |