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FDA 510(k)

ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B

K-Number: K972603 · 1998-03-11

ApplicantDr. Lee Co., Ltd.
Decision Date1998-03-11
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Lee Co., Ltd.. It received FDA 510(k) clearance on 1998-03-11 under 510(k) number K972603. 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 ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B?

ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B is a medical device that received FDA 510(k) clearance on 1998-03-11. The listed applicant is Dr. Lee Co., Ltd.. The 510(k) number is K972603.

When did ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B receive FDA 510(k) clearance?

ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B received FDA 510(k) clearance on 1998-03-11, under 510(k) number K972603.

Who is the listed applicant for ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B?

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

What is the FDA product code for ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B?

The FDA product code for ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B is DPS.

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Other records listing Dr. Lee Co., 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.

K972587ELECTROCARDIOGRAPHS

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

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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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