Pocket Colposcope System
K-Number: K181034 · 2018-09-21
ApplicantHadleigh Health Technologies, LLC
Decision Date2018-09-21
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Pocket Colposcope System is a medical device manufactured by Hadleigh Health Technologies, LLC. It received FDA 510(k) clearance on 2018-09-21 under approval number K181034. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pocket Colposcope System?
Pocket Colposcope System is a medical device that received FDA 510(k) clearance on 2018-09-21. It is manufactured by Hadleigh Health Technologies, LLC. The 510(k) number is K181034.
When was Pocket Colposcope System approved by the FDA?
Pocket Colposcope System received FDA 510(k) clearance on 2018-09-21, under approval number K181034.
What company makes Pocket Colposcope System?
Pocket Colposcope System is manufactured by Hadleigh Health Technologies, LLC.
What is the FDA product code for Pocket Colposcope System?
The FDA product code for Pocket Colposcope System is HEX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.