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 |