The following data is part of a premarket notification filed by Vasocor, Inc. with the FDA for Pvr-100/vasogram.
| Device ID | K990123 |
| 510k Number | K990123 |
| Device Name: | PVR-100/VASOGRAM |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | VASOCOR, INC. 7705 N.W. 48TH ST., SUITE 120 Miami, FL 33166 -5454 |
| Contact | Jeff Raines |
| Correspondent | Jeff Raines VASOCOR, INC. 7705 N.W. 48TH ST., SUITE 120 Miami, FL 33166 -5454 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-13 |
| Decision Date | 1999-04-12 |