The following data is part of a premarket notification filed by Hemodynamics, Inc. with the FDA for Light Reflection Rheography.
| Device ID | K852378 |
| 510k Number | K852378 |
| Device Name: | LIGHT REFLECTION RHEOGRAPHY |
| Classification | Plethysmograph, Impedance |
| Applicant | HEMODYNAMICS, INC. 1515 NORTH FEDERAL HIGHWAY Boca Raton, FL 33432 |
| Contact | Eugene Brown |
| Correspondent | Eugene Brown HEMODYNAMICS, INC. 1515 NORTH FEDERAL HIGHWAY Boca Raton, FL 33432 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-05 |
| Decision Date | 1985-06-20 |