FDA 510(k) Application Details - K233043

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K233043
Device Name	Colposcope (And Colpomicroscope)
Applicant	Periwinkle Technologies Pvt. Ltd B1, Samrat Ashok CHS, S. No. 88/2, Veerbhadra Nagar, Baner, Pune 411045 IN Other 510(k) Applications for this Company
Contact	Veena Moktali Other 510(k) Applications for this Contact
Regulation Number	884.1630   More FDA Info for this Regulation Number
Classification Product Code	HEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2023
Decision Date	06/14/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review