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FDA 510(k)

TSX PRM PULMONARY RESUSCITATION MONITOR

K-Number: K973347 · 1998-07-23

ApplicantSpiracle Technology
Decision Date1998-07-23
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TSX PRM PULMONARY RESUSCITATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Spiracle Technology. It received FDA 510(k) clearance on 1998-07-23 under 510(k) number K973347. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSX PRM PULMONARY RESUSCITATION MONITOR?

TSX PRM PULMONARY RESUSCITATION MONITOR is a medical device that received FDA 510(k) clearance on 1998-07-23. The listed applicant is Spiracle Technology. The 510(k) number is K973347.

When did TSX PRM PULMONARY RESUSCITATION MONITOR receive FDA 510(k) clearance?

TSX PRM PULMONARY RESUSCITATION MONITOR received FDA 510(k) clearance on 1998-07-23, under 510(k) number K973347.

Who is the listed applicant for TSX PRM PULMONARY RESUSCITATION MONITOR?

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

What is the FDA product code for TSX PRM PULMONARY RESUSCITATION MONITOR?

The FDA product code for TSX PRM PULMONARY RESUSCITATION MONITOR is CAP.

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 Spiracle Technology 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.

K982225SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504K963755SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATORK953349SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE

Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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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