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FDA 510(k)

PHYSIOGLOVE ES WITH ECG ANALYSIS

K-Number: K103791 · 2011-10-21

ApplicantCommwell , Ltd.
Decision Date2011-10-21
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHYSIOGLOVE ES WITH ECG ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Commwell , Ltd.. It received FDA 510(k) clearance on 2011-10-21 under 510(k) number K103791. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSIOGLOVE ES WITH ECG ANALYSIS?

PHYSIOGLOVE ES WITH ECG ANALYSIS is a medical device that received FDA 510(k) clearance on 2011-10-21. The listed applicant is Commwell , Ltd.. The 510(k) number is K103791.

When did PHYSIOGLOVE ES WITH ECG ANALYSIS receive FDA 510(k) clearance?

PHYSIOGLOVE ES WITH ECG ANALYSIS received FDA 510(k) clearance on 2011-10-21, under 510(k) number K103791.

Who is the listed applicant for PHYSIOGLOVE ES WITH ECG ANALYSIS?

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 ES WITH ECG ANALYSIS?

The FDA product code for PHYSIOGLOVE ES WITH ECG ANALYSIS is DPS.

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.

K083677PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1K050674PHYSIOGLOVE ES

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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