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)

COUNTER UNIT

K-Number: K792571 · 1979-12-19

ApplicantEmpire Plastics Manufacturer
Decision Date1979-12-19
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COUNTER UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Empire Plastics Manufacturer. It received FDA 510(k) clearance on 1979-12-19 under 510(k) number K792571. 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 COUNTER UNIT?

COUNTER UNIT is a medical device that received FDA 510(k) clearance on 1979-12-19. The listed applicant is Empire Plastics Manufacturer. The 510(k) number is K792571.

When did COUNTER UNIT receive FDA 510(k) clearance?

COUNTER UNIT received FDA 510(k) clearance on 1979-12-19, under 510(k) number K792571.

Who is the listed applicant for COUNTER UNIT?

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

What is the FDA product code for COUNTER UNIT?

The FDA product code for COUNTER UNIT 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 Empire Plastics Manufacturer 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.

K792573ALARM USED W/MONITORING SPIROMETERK792572EMPIRE SPIROMETERK790744LUNG FUNCTION AMPLIFIER EXERCISER

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.

↑