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FDA 510(k)

INSPIROMETER

K-Number: K833012 · 1983-11-08

ApplicantKinetix
Decision Date1983-11-08
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INSPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Kinetix. It received FDA 510(k) clearance on 1983-11-08 under 510(k) number K833012. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSPIROMETER?

INSPIROMETER is a medical device that received FDA 510(k) clearance on 1983-11-08. The listed applicant is Kinetix. The 510(k) number is K833012.

When did INSPIROMETER receive FDA 510(k) clearance?

INSPIROMETER received FDA 510(k) clearance on 1983-11-08, under 510(k) number K833012.

Who is the listed applicant for INSPIROMETER?

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

What is the FDA product code for INSPIROMETER?

The FDA product code for INSPIROMETER is BWF.

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 Kinetix 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.

K832401RESPIROMETERK840459IMPROVED MOUTHPIECEK833420KINETIX MOUTHPIECE

Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, Ltd.

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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