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FDA 510(k)

ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M

K-Number: K072217 · 2007-08-30

ApplicantNihon Kohden America, Inc.
Decision Date2007-08-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 2007-08-30 under 510(k) number K072217. 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 ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M?

ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M is a medical device that received FDA 510(k) clearance on 2007-08-30. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K072217.

When did ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M receive FDA 510(k) clearance?

ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M received FDA 510(k) clearance on 2007-08-30, under 510(k) number K072217.

Who is the listed applicant for ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M?

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

What is the FDA product code for ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M?

The FDA product code for ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M is DPS.

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Other records listing Nihon Kohden America, Inc. 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.

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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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