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FDA 510(k)

EMPIRE SPIROMETER

K-Number: K792572 · 1979-12-19

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

Device Summary

EMPIRE SPIROMETER 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 K792572. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPIRE SPIROMETER?

EMPIRE SPIROMETER 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 K792572.

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

EMPIRE SPIROMETER received FDA 510(k) clearance on 1979-12-19, under 510(k) number K792572.

Who is the listed applicant for EMPIRE SPIROMETER?

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 EMPIRE SPIROMETER?

The FDA product code for EMPIRE SPIROMETER is BZK.

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 SPIROMETERK792571COUNTER UNITK790744LUNG FUNCTION AMPLIFIER EXERCISER

Related Devices (Code: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, Inc.

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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