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FDA 510(k)

ATMOS S041 WOUND

K-Number: K090130 · 2009-04-02

ApplicantAtmos, Inc.
Decision Date2009-04-02
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATMOS S041 WOUND is the device name listed in this FDA 510(k) record. The listed applicant is Atmos, Inc.. It received FDA 510(k) clearance on 2009-04-02 under 510(k) number K090130. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATMOS S041 WOUND?

ATMOS S041 WOUND is a medical device that received FDA 510(k) clearance on 2009-04-02. The listed applicant is Atmos, Inc.. The 510(k) number is K090130.

When did ATMOS S041 WOUND receive FDA 510(k) clearance?

ATMOS S041 WOUND received FDA 510(k) clearance on 2009-04-02, under 510(k) number K090130.

Who is the listed applicant for ATMOS S041 WOUND?

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

What is the FDA product code for ATMOS S041 WOUND?

The FDA product code for ATMOS S041 WOUND is OMP.

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 Atmos, 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.

K103042ATMOS E 201 THORAX AND ATMOS S 201 THORAXK090445ATMOS C361/C451 SUCTION PUMP

Related Devices (Code: OMP)

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.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.

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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