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FDA 510(k)

MAX PULSE SYSTEM

K-Number: K110374 · 2011-06-13

ApplicantMedicore Co., Ltd.
Decision Date2011-06-13
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAX PULSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicore Co., Ltd.. It received FDA 510(k) clearance on 2011-06-13 under 510(k) number K110374. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAX PULSE SYSTEM?

MAX PULSE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-13. The listed applicant is Medicore Co., Ltd.. The 510(k) number is K110374.

When did MAX PULSE SYSTEM receive FDA 510(k) clearance?

MAX PULSE SYSTEM received FDA 510(k) clearance on 2011-06-13, under 510(k) number K110374.

Who is the listed applicant for MAX PULSE SYSTEM?

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

What is the FDA product code for MAX PULSE SYSTEM?

The FDA product code for MAX PULSE SYSTEM is JOM.

Related Clinical Trials

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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Other records listing Medicore 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.

K212412IRIS-XPK073323SA-3000P

Related Devices (Code: JOM)

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

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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