The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Command Ultra Ii.
Device ID | K831216 |
510k Number | K831216 |
Device Name: | COMMAND ULTRA II |
Classification | Implantable Pacemaker Pulse-generator |
Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXY |
CFR Regulation Number | 870.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-14 |
Decision Date | 1983-07-12 |