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FDA 510(k)

LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR

K-Number: K851662 · 1985-11-14

ApplicantLogos Medical Co., Ltd.
Decision Date1985-11-14
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR is the device name listed in this FDA 510(k) record. The listed applicant is Logos Medical Co., Ltd.. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K851662. 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 LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR?

LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Logos Medical Co., Ltd.. The 510(k) number is K851662.

When did LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR receive FDA 510(k) clearance?

LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR received FDA 510(k) clearance on 1985-11-14, under 510(k) number K851662.

Who is the listed applicant for LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR?

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

What is the FDA product code for LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR?

The FDA product code for LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR is DPS.

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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.

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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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