The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Syringe Infuser.
| Device ID | K933506 |
| 510k Number | K933506 |
| Device Name: | SYRINGE INFUSER |
| Classification | Pump, Infusion |
| Applicant | BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood, CO 80112 -3903 |
| Contact | Jeff Baldwin |
| Correspondent | Jeff Baldwin BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood, CO 80112 -3903 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-20 |
| Decision Date | 1994-02-25 |