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FDA 510(k)

MCPULSE

K-Number: K023238 · 2003-02-19

Decision Date2003-02-19
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MCPULSE is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Co., Ltd.. It received FDA 510(k) clearance on 2003-02-19 under 510(k) number K023238. 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 MCPULSE?

MCPULSE is a medical device that received FDA 510(k) clearance on 2003-02-19. The listed applicant is Meridian Co., Ltd.. The 510(k) number is K023238.

When did MCPULSE receive FDA 510(k) clearance?

MCPULSE received FDA 510(k) clearance on 2003-02-19, under 510(k) number K023238.

Who is the listed applicant for MCPULSE?

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

What is the FDA product code for MCPULSE?

The FDA product code for MCPULSE 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.

Other records listing Meridian 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.

View all 7 devices →

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.

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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