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FDA 510(k)

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK

K-Number: K102971 · 2011-02-23

ApplicantMicrotek Medical, Inc.
Decision Date2011-02-23
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK is the device name listed in this FDA 510(k) record. The listed applicant is Microtek Medical, Inc.. It received FDA 510(k) clearance on 2011-02-23 under 510(k) number K102971. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK?

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK is a medical device that received FDA 510(k) clearance on 2011-02-23. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K102971.

When did FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK receive FDA 510(k) clearance?

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK received FDA 510(k) clearance on 2011-02-23, under 510(k) number K102971.

Who is the listed applicant for FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK?

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

What is the FDA product code for FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK?

The FDA product code for FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK is FYA.

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Other records listing Microtek Medical, Inc. as applicant

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K110358VENODYNE V810K062899MICROTEK MEDICAL SURGICAL GOWN/TOGAK060200MICROTEK MEDICAL WARMING DRAPEK050322MICROTEK EQUIPMENT DRAPESK022903CHILLBUSTERK020956VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA

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Related Devices (Code: FYA)

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.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

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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