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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 the device name listed in this FDA 510(k) record. The listed applicant is Iob Medical, Inc.. It received FDA 510(k) clearance on 2021-03-30 under 510(k) 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. The listed applicant is Iob Medical, Inc.. The 510(k) number is K201896.

When did ivi N3003 Surgical face Mask, ivi N6006 Surgical mask receive FDA 510(k) clearance?

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

Who is the listed applicant for ivi N3003 Surgical face Mask, ivi N6006 Surgical mask?

The FDA 510(k) record lists Iob Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Iob Medical, Inc. 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.

K232638FilteredFlo Warming BlanketsK231596IOB Temperature Management SystemK221669IOB Warming BlanketsK190221IOB Warming BlanketsK162679IOB Temperature Management System

Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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