The following data is part of a premarket notification filed by Vasocor, Inc. with the FDA for Vasocor Pvr 100.
| Device ID | K973659 |
| 510k Number | K973659 |
| Device Name: | VASOCOR PVR 100 |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | VASOCOR, INC. 4001 NW 97TH AVE, SUITE 101 Miami, FL 33178 |
| Contact | Jeffery Raines |
| Correspondent | Jeffery Raines VASOCOR, INC. 4001 NW 97TH AVE, SUITE 101 Miami, FL 33178 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-25 |
| Decision Date | 1997-12-17 |
| Summary: | summary |