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FDA 510(k)

CAPNO-FLO(TM) REGULATOR

K-Number: K945822 · 1995-02-24

ApplicantKirk Specialty Systems
Decision Date1995-02-24
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNO-FLO(TM) REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Kirk Specialty Systems. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K945822. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPNO-FLO(TM) REGULATOR?

CAPNO-FLO(TM) REGULATOR is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Kirk Specialty Systems. The 510(k) number is K945822.

When did CAPNO-FLO(TM) REGULATOR receive FDA 510(k) clearance?

CAPNO-FLO(TM) REGULATOR received FDA 510(k) clearance on 1995-02-24, under 510(k) number K945822.

Who is the listed applicant for CAPNO-FLO(TM) REGULATOR?

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

What is the FDA product code for CAPNO-FLO(TM) REGULATOR?

The FDA product code for CAPNO-FLO(TM) REGULATOR is CBP.

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 Kirk Specialty 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.

K962098ESOPHAGEAL INTUBATION DETECTORK952512CAPNO-FLO REGULATOR, CAPNO-FLOK933626CAPNO-FLO

Related Devices (Code: CBP)

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.

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbHK234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic ASK192285CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou)K173770OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare LimitedK171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)Xiamen Compower Medical Tech. Co., 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.

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