The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Exacta-mix 2400 Compounding System, Model Exacta-mix 2400.
| Device ID | K002705 |
| 510k Number | K002705 |
| Device Name: | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood, CO 80112 -3903 |
| Contact | Carl Steineck |
| Correspondent | Carl Steineck BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood, CO 80112 -3903 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-30 |
| Decision Date | 2001-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412492112 | K002705 | 000 |
| 55413765492025 | K002705 | 000 |
| 55413765492032 | K002705 | 000 |
| 55413765492049 | K002705 | 000 |
| 50085412475771 | K002705 | 000 |
| 50085412475788 | K002705 | 000 |
| 50085412475795 | K002705 | 000 |
| 50085412475801 | K002705 | 000 |
| 50085412475818 | K002705 | 000 |
| 50085412477188 | K002705 | 000 |
| 50085412477300 | K002705 | 000 |
| 50085412492006 | K002705 | 000 |
| 55413765492018 | K002705 | 000 |