The following data is part of a premarket notification filed by Medical Electronic Systems, Llc with the FDA for Sqa V, Sperm Quality Analyzer.
| Device ID | K021746 |
| 510k Number | K021746 |
| Device Name: | SQA V, SPERM QUALITY ANALYZER |
| Classification | Semen Analysis Device |
| Applicant | MEDICAL ELECTRONIC SYSTEMS, LLC 269 SOUTH BEVERLY DR. #472 Beverly Hills, CA 90212 |
| Contact | Erica B Ammirati |
| Correspondent | Erica B Ammirati MEDICAL ELECTRONIC SYSTEMS, LLC 269 SOUTH BEVERLY DR. #472 Beverly Hills, CA 90212 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-28 |
| Decision Date | 2002-09-20 |