510(k) K181034
K181034 is an FDA 510(k) premarket notification submitted by Hadleigh Health Technologies, LLC for the device "Pocket Colposcope System". The FDA issued a decision of Substantially Equivalent on September 21, 2018. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Hadleigh Health Technologies, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2018
- Date Received
- April 18, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colposcope (And Colpomicroscope)
- Device Class
- Class II
- Regulation Number
- 884.1630
- Review Panel
- OB
- Submission Type