The following data is part of a premarket notification filed by Em-tec Gmbh with the FDA for Sono Tt Ultrasonic Flowcomputer.
| Device ID | K040909 |
| 510k Number | K040909 |
| Device Name: | SONO TT ULTRASONIC FLOWCOMPUTER |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | EM-TEC GMBH LERCHENBERG 20 Finning, DE 86923 |
| Contact | Andreas Knabe |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-08 |
| Decision Date | 2004-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04062114000297 | K040909 | 000 |
| 04062114000280 | K040909 | 000 |
| 04062114000266 | K040909 | 000 |