Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ID-Cap System

K-Number: K183052 · 2019-12-06

ApplicantEtectrx, Inc.
Decision Date2019-12-06
Product CodeOZW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ID-Cap System is a medical device manufactured by Etectrx, Inc.. It received FDA 510(k) clearance on 2019-12-06 under approval number K183052. The device is classified under product code OZW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ID-Cap System?

ID-Cap System is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Etectrx, Inc.. The 510(k) number is K183052.

When was ID-Cap System approved by the FDA?

ID-Cap System received FDA 510(k) clearance on 2019-12-06, under approval number K183052.

What company makes ID-Cap System?

ID-Cap System is manufactured by Etectrx, Inc..

What is the FDA product code for ID-Cap System?

The FDA product code for ID-Cap System is OZW.

Related Devices (Code: OZW)

K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.

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.

↑