The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Modified Betatron Iv Insulin Infusion System.
| Device ID | K900498 |
| 510k Number | K900498 |
| Device Name: | MODIFIED BETATRON IV INSULIN INFUSION SYSTEM |
| Classification | Pump, Infusion, Insulin |
| Applicant | CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Contact | Greg Mathison |
| Correspondent | Greg Mathison CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-18 |
| Decision Date | 1990-02-23 |