The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Gas Evacuation Accessory.
Device ID | K852772 |
510k Number | K852772 |
Device Name: | GAS EVACUATION ACCESSORY |
Classification | Apparatus, Gas-scavenging |
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 | CBN |
CFR Regulation Number | 868.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-27 |
Decision Date | 1985-10-10 |