The following data is part of a premarket notification filed by Jostra Ag with the FDA for Jostra Flowprobe Fp-32e.
| Device ID | K013939 |
| 510k Number | K013939 |
| Device Name: | JOSTRA FLOWPROBE FP-32E |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | JOSTRA AG 478 MEDIA RD. Oxford, PA 19363 |
| Contact | Kathleen Johnson |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-11-29 |
| Decision Date | 2001-12-14 |
| Summary: | summary |