510(k) K823209
K823209 is an FDA 510(k) premarket notification submitted by Bioself, Inc. for the device "BIOSELF 101". The FDA issued a decision of Substantially Equivalent on February 15, 1983. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device. Bioself, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 1983
- Date Received
- October 28, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fertility Diagnostic, Proceptive
- Device Class
- Class U
- Regulation Number
- Review Panel
- OB
- Submission Type