The following data is part of a premarket notification filed by Paradigm Medical Industries, Inc. with the FDA for Blood Flow Analyzer (bfa), Model 408-100-01.
| Device ID | K023245 |
| 510k Number | K023245 |
| Device Name: | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 |
| Classification | Tonometer, Analyzer, Ocular Blood Flow |
| Applicant | PARADIGM MEDICAL INDUSTRIES, INC. 2355 SOUTH 1070 WEST Salt Lake City, UT 84119 |
| Contact | David M Silver |
| Correspondent | David M Silver PARADIGM MEDICAL INDUSTRIES, INC. 2355 SOUTH 1070 WEST Salt Lake City, UT 84119 |
| Product Code | NJJ |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-30 |
| Decision Date | 2002-10-21 |
| Summary: | summary |