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FDA 510(k)

RESPITRACE 300SC

K-Number: K823780 · 1984-01-20

ApplicantRespitrace Corp.
Decision Date1984-01-20
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPITRACE 300SC is the device name listed in this FDA 510(k) record. The listed applicant is Respitrace Corp.. It received FDA 510(k) clearance on 1984-01-20 under 510(k) number K823780. 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 RESPITRACE 300SC?

RESPITRACE 300SC is a medical device that received FDA 510(k) clearance on 1984-01-20. The listed applicant is Respitrace Corp.. The 510(k) number is K823780.

When did RESPITRACE 300SC receive FDA 510(k) clearance?

RESPITRACE 300SC received FDA 510(k) clearance on 1984-01-20, under 510(k) number K823780.

Who is the listed applicant for RESPITRACE 300SC?

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

What is the FDA product code for RESPITRACE 300SC?

The FDA product code for RESPITRACE 300SC 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 Respitrace Corp. 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.

K854956RESPIGRAPHK852692RESPITRACE 300SCK823783RESPICOMBK823782RESPITRACE SYSTEMK772016RESPITRACE

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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