The following data is part of a premarket notification filed by Em-tec Gmbh with the FDA for Sonott Flowlab(r).
| Device ID | K111730 |
| 510k Number | K111730 |
| Device Name: | SONOTT FLOWLAB(R) |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | EM-TEC GMBH LERCHENBERG 20 Finning, DE 86923 |
| Contact | Bernhard Brand |
| Correspondent | Norbert Stuiber TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2012-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04062114000211 | K111730 | 000 |
| 04062114000105 | K111730 | 000 |
| 04062114000099 | K111730 | 000 |
| 04062114000082 | K111730 | 000 |
| 04062114000075 | K111730 | 000 |
| 04062114000068 | K111730 | 000 |
| 04062114000051 | K111730 | 000 |
| 04062114000044 | K111730 | 000 |
| 04062114000037 | K111730 | 000 |
| 04062114000112 | K111730 | 000 |
| 04062114000129 | K111730 | 000 |
| 04062114000204 | K111730 | 000 |
| 04062114000198 | K111730 | 000 |
| 04062114000181 | K111730 | 000 |
| 04062114000174 | K111730 | 000 |
| 04062114000167 | K111730 | 000 |
| 04062114000150 | K111730 | 000 |
| 04062114000143 | K111730 | 000 |
| 04062114000136 | K111730 | 000 |
| 04062114000013 | K111730 | 000 |