The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Siemens Cardiostat 701.
Device ID | K790794 |
510k Number | K790794 |
Device Name: | SIEMENS CARDIOSTAT 701 |
Classification | Electrocardiograph |
Applicant | ELMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-24 |
Decision Date | 1979-05-31 |