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FDA 510(k)

AIR SAFETY HEPA, MODEL 3500

K-Number: K040712 · 2004-06-03

ApplicantAir Safety, Ltd.
Decision Date2004-06-03
Product CodeMOD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR SAFETY HEPA, MODEL 3500 is the device name listed in this FDA 510(k) record. The listed applicant is Air Safety, Ltd.. It received FDA 510(k) clearance on 2004-06-03 under 510(k) number K040712. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR SAFETY HEPA, MODEL 3500?

AIR SAFETY HEPA, MODEL 3500 is a medical device that received FDA 510(k) clearance on 2004-06-03. The listed applicant is Air Safety, Ltd.. The 510(k) number is K040712.

When did AIR SAFETY HEPA, MODEL 3500 receive FDA 510(k) clearance?

AIR SAFETY HEPA, MODEL 3500 received FDA 510(k) clearance on 2004-06-03, under 510(k) number K040712.

Who is the listed applicant for AIR SAFETY HEPA, MODEL 3500?

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

What is the FDA product code for AIR SAFETY HEPA, MODEL 3500?

The FDA product code for AIR SAFETY HEPA, MODEL 3500 is MOD.

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 Air Safety, Ltd. 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.

K051712MODEL 2800 PFT FILTERK050953AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLEK033008AIR SAFETY HEPA AND NON-HEPA FILTERS

Related Devices (Code: MOD)

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.

K261360EasyCare Tx 2Resmed CorpK253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences , Ltd.K260051CorVision® (91-205-Z0014)CorVent® Medical, Inc.K242485EveryWareBreas Medical ABK161411Care Cycle Connect ApplicationRespironics, Inc.K091461BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUECardiopulmonary Corp.

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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