The following data is part of a premarket notification filed by Health Watch, Inc. with the FDA for Pacer Model 100 Infusion Controller.
| Device ID | K963136 |
| 510k Number | K963136 |
| Device Name: | PACER MODEL 100 INFUSION CONTROLLER |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | HEALTH WATCH, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Contact | John D Greenbaum |
| Correspondent | John D Greenbaum HEALTH WATCH, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-13 |
| Decision Date | 1997-10-10 |