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FDA 510(k)

CSF400 AND CSF600

K-Number: K030081 · 2003-10-06

ApplicantInmed Ltda.
Decision Date2003-10-06
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CSF400 AND CSF600 is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Ltda.. It received FDA 510(k) clearance on 2003-10-06 under 510(k) number K030081. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSF400 AND CSF600?

CSF400 AND CSF600 is a medical device that received FDA 510(k) clearance on 2003-10-06. The listed applicant is Inmed Ltda.. The 510(k) number is K030081.

When did CSF400 AND CSF600 receive FDA 510(k) clearance?

CSF400 AND CSF600 received FDA 510(k) clearance on 2003-10-06, under 510(k) number K030081.

Who is the listed applicant for CSF400 AND CSF600?

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

What is the FDA product code for CSF400 AND CSF600?

The FDA product code for CSF400 AND CSF600 is JXG.

Other records listing Inmed Ltda. 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.

K030887LEKTROGEL, MODEL LK3001K030889ULTRAEKOGEL MODELS EK 2000 & EK 2001

Related Devices (Code: JXG)

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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