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FDA 510(k)

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask

K-Number: K201896 · 2021-03-30

ApplicantIob Medical, Inc.
Decision Date2021-03-30
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask is a medical device manufactured by Iob Medical, Inc.. It received FDA 510(k) clearance on 2021-03-30 under approval number K201896. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ivi N3003 Surgical face Mask, ivi N6006 Surgical mask?

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask is a medical device that received FDA 510(k) clearance on 2021-03-30. It is manufactured by Iob Medical, Inc.. The 510(k) number is K201896.

When was ivi N3003 Surgical face Mask, ivi N6006 Surgical mask approved by the FDA?

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask received FDA 510(k) clearance on 2021-03-30, under approval number K201896.

What company makes ivi N3003 Surgical face Mask, ivi N6006 Surgical mask?

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask is manufactured by Iob Medical, Inc..

What is the FDA product code for ivi N3003 Surgical face Mask, ivi N6006 Surgical mask?

The FDA product code for ivi N3003 Surgical face Mask, ivi N6006 Surgical mask is FXX.

Other Devices by Iob Medical, Inc.

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Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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