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FDA 510(k)

MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K070239 · 2007-05-25

ApplicantExir Pharmaceutical Co.
Decision Date2007-05-25
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Exir Pharmaceutical Co.. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K070239. 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 MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM?

MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Exir Pharmaceutical Co.. The 510(k) number is K070239.

When did MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2007-05-25, under 510(k) number K070239.

Who is the listed applicant for MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

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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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