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FDA 510(k)

LERADOTECH, MODEL SC

K-Number: K070802 · 2007-04-13

Decision Date2007-04-13
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LERADOTECH, MODEL SC is the device name listed in this FDA 510(k) record. The listed applicant is Lerado China Limited. It received FDA 510(k) clearance on 2007-04-13 under 510(k) number K070802. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LERADOTECH, MODEL SC?

LERADOTECH, MODEL SC is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Lerado China Limited. The 510(k) number is K070802.

When did LERADOTECH, MODEL SC receive FDA 510(k) clearance?

LERADOTECH, MODEL SC received FDA 510(k) clearance on 2007-04-13, under 510(k) number K070802.

Who is the listed applicant for LERADOTECH, MODEL SC?

The FDA 510(k) record lists Lerado China Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LERADOTECH, MODEL SC?

The FDA product code for LERADOTECH, MODEL SC is INI.

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 Lerado China Limited 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.

Related Devices (Code: INI)

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

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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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