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FDA 510(k)

PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1

K-Number: K083677 · 2009-03-10

ApplicantCommwell , Ltd.
Decision Date2009-03-10
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 is the device name listed in this FDA 510(k) record. The listed applicant is Commwell , Ltd.. It received FDA 510(k) clearance on 2009-03-10 under 510(k) number K083677. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1?

PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 is a medical device that received FDA 510(k) clearance on 2009-03-10. The listed applicant is Commwell , Ltd.. The 510(k) number is K083677.

When did PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 receive FDA 510(k) clearance?

PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 received FDA 510(k) clearance on 2009-03-10, under 510(k) number K083677.

Who is the listed applicant for PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1?

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

What is the FDA product code for PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1?

The FDA product code for PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 is DRX.

Related Clinical Trials

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Other records listing Commwell , Ltd. 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.

K103791PHYSIOGLOVE ES WITH ECG ANALYSISK050674PHYSIOGLOVE ES

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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.

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