The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Arrhythmia Ii Cardule.
Device ID | K790837 |
510k Number | K790837 |
Device Name: | ARRHYTHMIA II CARDULE |
Classification | Detector And Alarm, Arrhythmia |
Applicant | SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-30 |
Decision Date | 1979-05-16 |