The following data is part of a premarket notification filed by Emed Technologies Corporation with the FDA for Infuset Flow Control Extension Set.
| Device ID | K140133 |
| 510k Number | K140133 |
| Device Name: | INFUSET FLOW CONTROL EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | EMED TECHNOLOGIES CORPORATION 1264 Hawks Flight Ct Ste 200 El Dorado Hills, CA 95762 |
| Contact | Peter Kollings |
| Correspondent | Peter Kollings EMED TECHNOLOGIES CORPORATION 1264 Hawks Flight Ct Ste 200 El Dorado Hills, CA 95762 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-17 |
| Decision Date | 2014-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817708021943 | K140133 | 000 |
| 00817708020342 | K140133 | 000 |
| 00817708020366 | K140133 | 000 |
| 00817708020380 | K140133 | 000 |
| 00817708020403 | K140133 | 000 |
| 00817708020427 | K140133 | 000 |
| 00817708020441 | K140133 | 000 |
| 00817708020465 | K140133 | 000 |
| 00817708020489 | K140133 | 000 |
| 00817708020502 | K140133 | 000 |
| 00817708021905 | K140133 | 000 |
| 00817708021929 | K140133 | 000 |
| 00817708020328 | K140133 | 000 |