The following data is part of a premarket notification filed by Pacesetter, Inc. with the FDA for Siemens Servo Ultra Nebulizer 345.
| Device ID | K960854 |
| 510k Number | K960854 |
| Device Name: | SIEMENS SERVO ULTRA NEBULIZER 345 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PACESETTER, INC. 49 PLAIN ST. North Attleboro, MA 02760 -3577 |
| Contact | Steven Clarke |
| Correspondent | Steven Clarke PACESETTER, INC. 49 PLAIN ST. North Attleboro, MA 02760 -3577 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-01 |
| Decision Date | 1996-12-23 |
| Summary: | summary |