FDA 510(k)

DIDGET WORLD REPORTS

K-Number: K093930 · 2010-03-12

Decision Date2010-03-12

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIDGET WORLD REPORTS is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2010-03-12 under 510(k) number K093930. 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 DIDGET WORLD REPORTS?

DIDGET WORLD REPORTS is a medical device that received FDA 510(k) clearance on 2010-03-12. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K093930.

When did DIDGET WORLD REPORTS receive FDA 510(k) clearance?

DIDGET WORLD REPORTS received FDA 510(k) clearance on 2010-03-12, under 510(k) number K093930.

Who is the listed applicant for DIDGET WORLD REPORTS?

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

What is the FDA product code for DIDGET WORLD REPORTS?

The FDA product code for DIDGET WORLD REPORTS 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.