The following data is part of a premarket notification filed by Vasocom, Inc. with the FDA for Physioflow Enduro.
| Device ID | K103283 |
| 510k Number | K103283 |
| Device Name: | PHYSIOFLOW ENDURO |
| Classification | Plethysmograph, Impedance |
| Applicant | VASOCOM, INC. 2014 FORD RD., UNIT G Bristol, PA 19007 |
| Contact | James Gunnerson |
| Correspondent | James Gunnerson VASOCOM, INC. 2014 FORD RD., UNIT G Bristol, PA 19007 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-05 |
| Decision Date | 2010-12-03 |
| Summary: | summary |