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FDA 510(k)

MODIFICATION TO DATACAPTOR

K-Number: K020197 · 2002-02-21

ApplicantCapsule Technologie
Decision Date2002-02-21
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO DATACAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Capsule Technologie. It received FDA 510(k) clearance on 2002-02-21 under 510(k) number K020197. 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 MODIFICATION TO DATACAPTOR?

MODIFICATION TO DATACAPTOR is a medical device that received FDA 510(k) clearance on 2002-02-21. The listed applicant is Capsule Technologie. The 510(k) number is K020197.

When did MODIFICATION TO DATACAPTOR receive FDA 510(k) clearance?

MODIFICATION TO DATACAPTOR received FDA 510(k) clearance on 2002-02-21, under 510(k) number K020197.

Who is the listed applicant for MODIFICATION TO DATACAPTOR?

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

What is the FDA product code for MODIFICATION TO DATACAPTOR?

The FDA product code for MODIFICATION TO DATACAPTOR 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.

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Other records listing Capsule Technologie as applicant

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.

K183638SmartLinx Vitals Plus Patient Monitoring SystemK180734SmartLinx Vitals Plus Patient Monitoring SystemK032142DATACAPTORK013019DATACAPTOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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