The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Microfuse Dual Rate Infuser.
| Device ID | K983321 |
| 510k Number | K983321 |
| Device Name: | MICROFUSE DUAL RATE INFUSER |
| Classification | Pump, Infusion |
| Applicant | BAXA CORP. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Contact | William E Mckay |
| Correspondent | William E Mckay BAXA CORP. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-22 |
| Decision Date | 1998-10-06 |
| Summary: | summary |