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FDA 510(k)

SA-3000P

K-Number: K073323 · 2007-11-29

ApplicantMedicore Co., Ltd.
Decision Date2007-11-29
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SA-3000P 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 2007-11-29 under 510(k) number K073323. 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 SA-3000P?

SA-3000P is a medical device that received FDA 510(k) clearance on 2007-11-29. The listed applicant is Medicore Co., Ltd.. The 510(k) number is K073323.

When did SA-3000P receive FDA 510(k) clearance?

SA-3000P received FDA 510(k) clearance on 2007-11-29, under 510(k) number K073323.

Who is the listed applicant for SA-3000P?

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 SA-3000P?

The FDA product code for SA-3000P is JOM.

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-XPK110374MAX PULSE SYSTEM

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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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