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FDA 510(k)

X-AIR-CISER

K-Number: K974849 · 1998-08-06

ApplicantHougen Mfg., Inc.
Decision Date1998-08-06
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

X-AIR-CISER is the device name listed in this FDA 510(k) record. The listed applicant is Hougen Mfg., Inc.. It received FDA 510(k) clearance on 1998-08-06 under 510(k) number K974849. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-AIR-CISER?

X-AIR-CISER is a medical device that received FDA 510(k) clearance on 1998-08-06. The listed applicant is Hougen Mfg., Inc.. The 510(k) number is K974849.

When did X-AIR-CISER receive FDA 510(k) clearance?

X-AIR-CISER received FDA 510(k) clearance on 1998-08-06, under 510(k) number K974849.

Who is the listed applicant for X-AIR-CISER?

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

What is the FDA product code for X-AIR-CISER?

The FDA product code for X-AIR-CISER is BYI.

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 Hougen Mfg., 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.

K974848MINI-CISER

Related Devices (Code: BYI)

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.

K252849AffloVest® Mobile Airway Clearance TherapyTactile MedicalK250860BreatheBand® (Model 1000)Exemplar Medical, LLCK242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K233441The Vest APX System (PVAPX1)Baxter Healthcare CorportationK222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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