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FDA 510(k)

STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031

K-Number: K043004 · 2005-03-16

ApplicantViasys Medsystems
Decision Date2005-03-16
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Medsystems. It received FDA 510(k) clearance on 2005-03-16 under 510(k) number K043004. 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 STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031?

STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 is a medical device that received FDA 510(k) clearance on 2005-03-16. The listed applicant is Viasys Medsystems. The 510(k) number is K043004.

When did STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 receive FDA 510(k) clearance?

STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 received FDA 510(k) clearance on 2005-03-16, under 510(k) number K043004.

Who is the listed applicant for STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031?

The FDA 510(k) record lists Viasys Medsystems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031?

The FDA product code for STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 is FYA.

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Related Devices (Code: FYA)

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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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