FDA 510(k)

G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A

K-Number: K082201 · 2009-02-20

Decision Date2009-02-20

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A 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 2009-02-20 under 510(k) number K082201. 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 G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A?

G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K082201.

When did G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A receive FDA 510(k) clearance?

G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A received FDA 510(k) clearance on 2009-02-20, under 510(k) number K082201.

Who is the listed applicant for G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A?

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 G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A?

The FDA product code for G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A 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.