The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Nebulizer Accessory For Servo Ventill.
Device ID | K832898 |
510k Number | K832898 |
Device Name: | NEBULIZER ACCESSORY FOR SERVO VENTILL |
Classification | Nebulizer (direct Patient Interface) |
Applicant | SIEMENS ELEMA AB 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-26 |
Decision Date | 1983-11-25 |