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FDA 510(k)

EZ SMART

K-Number: K040848 · 2004-08-11

ApplicantVip International Wholesalers, Corp.
Decision Date2004-08-11
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EZ SMART is the device name listed in this FDA 510(k) record. The listed applicant is Vip International Wholesalers, Corp.. It received FDA 510(k) clearance on 2004-08-11 under 510(k) number K040848. 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 EZ SMART?

EZ SMART is a medical device that received FDA 510(k) clearance on 2004-08-11. The listed applicant is Vip International Wholesalers, Corp.. The 510(k) number is K040848.

When did EZ SMART receive FDA 510(k) clearance?

EZ SMART received FDA 510(k) clearance on 2004-08-11, under 510(k) number K040848.

Who is the listed applicant for EZ SMART?

The FDA 510(k) record lists Vip International Wholesalers, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ SMART?

The FDA product code for EZ SMART 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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