510(k) K192845
K192845 is an FDA 510(k) premarket notification submitted by Kitazato Corporation for the device "Sperm Freeze, Sperm Fridge". The FDA issued a decision of Substantially Equivalent on August 17, 2020. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Kitazato Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2020
- Date Received
- October 3, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type