The following data is part of a premarket notification filed by Unetixs, Inc. with the FDA for Multilab 2000.
| Device ID | K904392 |
| 510k Number | K904392 |
| Device Name: | MULTILAB 2000 |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | UNETIXS, INC. 25 RESERVOIR AVE. Providence, RI 02907 |
| Contact | John Haefele |
| Correspondent | John Haefele UNETIXS, INC. 25 RESERVOIR AVE. Providence, RI 02907 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1991-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B437129500 | K904392 | 000 |
| B4371199606 | K904392 | 000 |
| B4371198605 | K904392 | 000 |
| B4371194904 | K904392 | 000 |