The following data is part of a premarket notification filed by Analytica Pty Ltd with the FDA for Autostart Burette.
| Device ID | K092905 |
| 510k Number | K092905 |
| Device Name: | AUTOSTART BURETTE |
| Classification | Set, Administration, Intravascular |
| Applicant | ANALYTICA PTY LTD PO BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan ANALYTICA PTY LTD PO BOX 560 Stillwater, MN 55082 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2010-03-04 |
| Summary: | summary |