The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Ultra Software Module: Model 2016.
| Device ID | K863046 |
| 510k Number | K863046 |
| Device Name: | ULTRA SOFTWARE MODULE: MODEL 2016 |
| Classification | Programmer, Pacemaker |
| Applicant | CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Contact | Ann Morrissey |
| Correspondent | Ann Morrissey CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Product Code | KRG |
| CFR Regulation Number | 870.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-12 |
| Decision Date | 1986-12-05 |