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FDA 510(k)

G4, MODEL IGM-0004

K-Number: K051651 · 2006-04-14

ApplicantU. S. Diagnostics, Inc.
Decision Date2006-04-14
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

G4, MODEL IGM-0004 is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 2006-04-14 under 510(k) number K051651. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G4, MODEL IGM-0004?

G4, MODEL IGM-0004 is a medical device that received FDA 510(k) clearance on 2006-04-14. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K051651.

When did G4, MODEL IGM-0004 receive FDA 510(k) clearance?

G4, MODEL IGM-0004 received FDA 510(k) clearance on 2006-04-14, under 510(k) number K051651.

Who is the listed applicant for G4, MODEL IGM-0004?

The FDA 510(k) record lists U. S. Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G4, MODEL IGM-0004?

The FDA product code for G4, MODEL IGM-0004 is NBW. This falls under the OB/GYN category.

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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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