510(k) K823463
K823463 is an FDA 510(k) premarket notification submitted by P.K. Morgan Instruments, Inc. for the device "RIGHT TIME RHYTHM CLOCK". The FDA issued a decision of Substantially Equivalent on March 17, 1983. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device. P.K. Morgan Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1983
- Date Received
- November 19, 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