The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Servo Cart 170.
Device ID | K840264 |
510k Number | K840264 |
Device Name: | SERVO CART 170 |
Classification | Cart, Emergency, Cardiopulmonary (excluding Equipment) |
Applicant | SIEMENS ELEMA AB 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZN |
CFR Regulation Number | 868.6175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-23 |
Decision Date | 1984-02-04 |