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

FDA 510(k)

DATACAPTOR SYSTEM

K-Number: K113835 · 2012-06-27

ApplicantCapsule Tech, Inc.
Decision Date2012-06-27
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATACAPTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Capsule Tech, Inc.. It received FDA 510(k) clearance on 2012-06-27 under 510(k) number K113835. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATACAPTOR SYSTEM?

DATACAPTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-27. The listed applicant is Capsule Tech, Inc.. The 510(k) number is K113835.

When did DATACAPTOR SYSTEM receive FDA 510(k) clearance?

DATACAPTOR SYSTEM received FDA 510(k) clearance on 2012-06-27, under 510(k) number K113835.

Who is the listed applicant for DATACAPTOR SYSTEM?

The FDA 510(k) record lists Capsule Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATACAPTOR SYSTEM?

The FDA product code for DATACAPTOR SYSTEM is MWI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.

↑