The following data is part of a premarket notification filed by Entlab Oy with the FDA for Ultramax/model Number A1.
| Device ID | K960044 |
| 510k Number | K960044 |
| Device Name: | ULTRAMAX/MODEL NUMBER A1 |
| Classification | Ultrasound, Sinus |
| Applicant | ENTLAB OY 5671 SANDIFORD PLACE Richmond, CA V7e 5m5 |
| Contact | Matti Revonta |
| Correspondent | Matti Revonta ENTLAB OY 5671 SANDIFORD PLACE Richmond, CA V7e 5m5 |
| Product Code | LWI |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-08-02 |
| Summary: | summary |