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FDA 510(k)

NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES

K-Number: K984504 · 1999-04-15

ApplicantNihon Kohden America, Inc.
Decision Date1999-04-15
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES 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 1999-04-15 under 510(k) number K984504. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES?

NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1999-04-15. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K984504.

When did NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES receive FDA 510(k) clearance?

NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES received FDA 510(k) clearance on 1999-04-15, under 510(k) number K984504.

Who is the listed applicant for NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES?

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 NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES?

The FDA product code for NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES is LOS.

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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: LOS)

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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., Inc.

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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