The following data is part of a premarket notification filed by Motion Analysis Corp. with the FDA for Cts-3060 Automated Semen Analyzer.
| Device ID | K881765 |
| 510k Number | K881765 |
| Device Name: | CTS-3060 AUTOMATED SEMEN ANALYZER |
| Classification | Semen Analysis Device |
| Applicant | MOTION ANALYSIS CORP. 3650 NORTH LAUGHLIN RD. Santa Rosa, CA 95403 |
| Contact | Hand, Phd |
| Correspondent | Hand, Phd MOTION ANALYSIS CORP. 3650 NORTH LAUGHLIN RD. Santa Rosa, CA 95403 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-25 |
| Decision Date | 1989-02-15 |