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FDA 510(k)

CAPNO-FLO REGULATOR, CAPNO-FLO

K-Number: K952512 · 1995-08-28

ApplicantKirk Specialty Systems
Decision Date1995-08-28
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNO-FLO REGULATOR, CAPNO-FLO 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 1995-08-28 under 510(k) number K952512. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPNO-FLO REGULATOR, CAPNO-FLO?

CAPNO-FLO REGULATOR, CAPNO-FLO is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Kirk Specialty Systems. The 510(k) number is K952512.

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

CAPNO-FLO REGULATOR, CAPNO-FLO received FDA 510(k) clearance on 1995-08-28, under 510(k) number K952512.

Who is the listed applicant for CAPNO-FLO REGULATOR, CAPNO-FLO?

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 REGULATOR, CAPNO-FLO?

The FDA product code for CAPNO-FLO REGULATOR, CAPNO-FLO is BTM.

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 DETECTORK945822CAPNO-FLO(TM) REGULATORK933626CAPNO-FLO

Related Devices (Code: BTM)

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.

K251631The BAG manual resuscitator and accessoriesLaerdal Medical ASK243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited.

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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