The following data is part of a premarket notification filed by Medical Electronic Systems, Llc with the FDA for Sqa, Sperm Quality Analyzer.
| Device ID | K012352 |
| 510k Number | K012352 |
| Device Name: | SQA, SPERM QUALITY ANALYZER |
| Classification | Semen Analysis Device |
| Applicant | MEDICAL ELECTRONIC SYSTEMS, LLC 6363 GREENWICH DR. SUITE 220 San Diego, CA 92122 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati MEDICAL ELECTRONIC SYSTEMS, LLC 6363 GREENWICH DR. SUITE 220 San Diego, CA 92122 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-25 |
| Decision Date | 2001-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016650037 | K012352 | 000 |
| 07290012140792 | K012352 | 000 |