The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Gas Supply Manifold Siemens-elema Ab.
Device ID | K840326 |
510k Number | K840326 |
Device Name: | GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB |
Classification | Yoke Assembly, Medical Gas |
Applicant | SIEMENS ELEMA AB 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAM |
CFR Regulation Number | 868.6885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-25 |
Decision Date | 1984-06-07 |