The following data is part of a premarket notification filed by Vasocom, Inc. with the FDA for Physioflow System.
| Device ID | K060387 |
| 510k Number | K060387 |
| Device Name: | PHYSIOFLOW SYSTEM |
| Classification | Plethysmograph, Impedance |
| Applicant | VASOCOM, INC. 2014 FORD RD., UNIT G Bristol, PA 19007 |
| Contact | Stephen Staats |
| Correspondent | Stephen Staats VASOCOM, INC. 2014 FORD RD., UNIT G Bristol, PA 19007 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2008-04-10 |
| Summary: | summary |