510(k) K073039
K073039 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "SPERMCHECK VASECTOMY". The FDA issued a decision of Substantially Equivalent on January 24, 2008. The device falls under product code POV (Semen Analysis Device), a Class II device regulated under 21 CFR 864.5220. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 2008
- Date Received
- October 29, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Semen Analysis Device
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.