Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DYNASTY ISOLATION GOWN

K-Number: K922234 · 1992-08-11

ApplicantDynatech Medical Products
Decision Date1992-08-11
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DYNASTY ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Medical Products. It received FDA 510(k) clearance on 1992-08-11 under 510(k) number K922234. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNASTY ISOLATION GOWN?

DYNASTY ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 1992-08-11. The listed applicant is Dynatech Medical Products. The 510(k) number is K922234.

When did DYNASTY ISOLATION GOWN receive FDA 510(k) clearance?

DYNASTY ISOLATION GOWN received FDA 510(k) clearance on 1992-08-11, under 510(k) number K922234.

Who is the listed applicant for DYNASTY ISOLATION GOWN?

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

What is the FDA product code for DYNASTY ISOLATION GOWN?

The FDA product code for DYNASTY ISOLATION GOWN is FYC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dynatech Medical Products 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.

K923188DYNASTY IMPERVIOUS ISOLATION J-SUITK923187IMPERVIOUS ISOLATION SHOE COVERSK893520DR. BOO LATEX EXAMINATION GLOVESK770730PUMP, INFUSION, DYNATECH/HANDLEY

Related Devices (Code: FYC)

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.

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, 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.

↑