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)

INCENTIVE SPIROMETER

K-Number: K000314 · 2000-04-12

ApplicantEngineered Medical Systems
Decision Date2000-04-12
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INCENTIVE SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems. It received FDA 510(k) clearance on 2000-04-12 under 510(k) number K000314. 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 INCENTIVE SPIROMETER?

INCENTIVE SPIROMETER is a medical device that received FDA 510(k) clearance on 2000-04-12. The listed applicant is Engineered Medical Systems. The 510(k) number is K000314.

When did INCENTIVE SPIROMETER receive FDA 510(k) clearance?

INCENTIVE SPIROMETER received FDA 510(k) clearance on 2000-04-12, under 510(k) number K000314.

Who is the listed applicant for INCENTIVE SPIROMETER?

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

What is the FDA product code for INCENTIVE SPIROMETER?

The FDA product code for INCENTIVE SPIROMETER 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 Engineered Medical Systems 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.

K023683MULTI-STRAP FULL FACE MASKK013728TRACH VOXK013122EMS ELECTROSTATIC FLITER AND HME COMBINATIONK013123EMS PULMONARY FUNCTION TESTING FILTERK013089EMS HEPA FILTER AND HME COMBINATIONSK003497DISPOSABLE PRESSURE MONITOR

View all 22 devices →

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

View on FDA Database →

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

↑