The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Nouvag Ag - Vacuson 40 And Vacuson 60.
| Device ID | K042943 |
| 510k Number | K042943 |
| Device Name: | NOUVAG AG - VACUSON 40 AND VACUSON 60 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Contact | Erich Forster |
| Correspondent | Erich Forster NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-25 |
| Decision Date | 2004-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ENOU42801150 | K042943 | 000 |
| ENOU42751150 | K042943 | 000 |
| ENOU42271150 | K042943 | 000 |
| ENOU4245USA9 | K042943 | 000 |
| ENOU4052USA9 | K042943 | 000 |