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FDA 510(k)

MICRODOT XTRA

K-Number: K083273 · 2009-11-19

ApplicantCambridge Sensors Limited
Decision Date2009-11-19
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRODOT XTRA is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Sensors Limited. It received FDA 510(k) clearance on 2009-11-19 under 510(k) number K083273. 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 MICRODOT XTRA?

MICRODOT XTRA is a medical device that received FDA 510(k) clearance on 2009-11-19. The listed applicant is Cambridge Sensors Limited. The 510(k) number is K083273.

When did MICRODOT XTRA receive FDA 510(k) clearance?

MICRODOT XTRA received FDA 510(k) clearance on 2009-11-19, under 510(k) number K083273.

Who is the listed applicant for MICRODOT XTRA?

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

What is the FDA product code for MICRODOT XTRA?

The FDA product code for MICRODOT XTRA is NBW. This falls under the OB/GYN category.

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Other records listing Cambridge Sensors Limited 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.

K102383MICRODOT & MICRODOT XTRAK070524MICRODOT BLOOD GLUCOSE MONITORING SYSTEM

Related Devices (Code: NBW)

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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