The following data is part of a premarket notification filed by Medi-stim A/s with the FDA for Medi-stim Butterfly Flowmeter, Model Bf1000-bf2004.
| Device ID | K992305 |
| 510k Number | K992305 |
| Device Name: | MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | MEDI-STIM A/S PO BOX 35 GREFSEN,N-0409 OSLO SANDAKERVEIEN 110 Oslo, NO N-0475 |
| Contact | Jon H Hoem |
| Correspondent | Jon H Hoem MEDI-STIM A/S PO BOX 35 GREFSEN,N-0409 OSLO SANDAKERVEIEN 110 Oslo, NO N-0475 |
| Product Code | ITX |
| Subsequent Product Code | DPT |
| Subsequent Product Code | DPW |
| Subsequent Product Code | DSK |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-08 |
| Decision Date | 1999-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07070554101181 | K992305 | 000 |
| 07070554100962 | K992305 | 000 |
| 07070554100955 | K992305 | 000 |
| 07070554100856 | K992305 | 000 |
| 07070554100849 | K992305 | 000 |
| 07070554100832 | K992305 | 000 |
| 07070554100825 | K992305 | 000 |
| 07070554100818 | K992305 | 000 |
| 07070554100764 | K992305 | 000 |
| 07070554100757 | K992305 | 000 |
| 07070554100733 | K992305 | 000 |
| 07070554100726 | K992305 | 000 |
| 07070554100719 | K992305 | 000 |
| 07070554100092 | K992305 | 000 |
| 07070554100085 | K992305 | 000 |
| 07070554100078 | K992305 | 000 |
| 07070554100979 | K992305 | 000 |
| 07070554100986 | K992305 | 000 |
| 07070554100993 | K992305 | 000 |
| 07070554101174 | K992305 | 000 |
| 07070554101167 | K992305 | 000 |
| 07070554101150 | K992305 | 000 |
| 07070554101143 | K992305 | 000 |
| 07070554101136 | K992305 | 000 |
| 07070554101129 | K992305 | 000 |
| 07070554101112 | K992305 | 000 |
| 07070554101082 | K992305 | 000 |
| 07070554101075 | K992305 | 000 |
| 07070554101068 | K992305 | 000 |
| 07070554101051 | K992305 | 000 |
| 07070554101044 | K992305 | 000 |
| 07070554101037 | K992305 | 000 |
| 07070554101020 | K992305 | 000 |
| 07070554101006 | K992305 | 000 |
| 07070554100061 | K992305 | 000 |