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FDA 510(k)

ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0

K-Number: K070021 · 2007-12-07

ApplicantJg Medical Products, LLC
Decision Date2007-12-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Jg Medical Products, LLC. It received FDA 510(k) clearance on 2007-12-07 under 510(k) number K070021. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0?

ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 is a medical device that received FDA 510(k) clearance on 2007-12-07. The listed applicant is Jg Medical Products, LLC. The 510(k) number is K070021.

When did ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 receive FDA 510(k) clearance?

ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 received FDA 510(k) clearance on 2007-12-07, under 510(k) number K070021.

Who is the listed applicant for ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0?

The FDA 510(k) record lists Jg Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0?

The FDA product code for ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 is HRX.

Related Clinical Trials

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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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