The following data is part of a premarket notification filed by Paradigm Medical Industries, Inc. with the FDA for Ultrasonic Bio-microscope, Model P60.
| Device ID | K050980 |
| 510k Number | K050980 |
| Device Name: | ULTRASONIC BIO-MICROSCOPE, MODEL P60 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PARADIGM MEDICAL INDUSTRIES, INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll PARADIGM MEDICAL INDUSTRIES, INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-19 |
| Decision Date | 2005-05-26 |
| Summary: | summary |