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FDA 510(k)

GIO DIGITAL PRESSURE GUAGES

K-Number: K122627 · 2013-08-22

ApplicantGalemed Corp.
Decision Date2013-08-22
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GIO DIGITAL PRESSURE GUAGES is the device name listed in this FDA 510(k) record. The listed applicant is Galemed Corp.. It received FDA 510(k) clearance on 2013-08-22 under 510(k) number K122627. 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 GIO DIGITAL PRESSURE GUAGES?

GIO DIGITAL PRESSURE GUAGES is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Galemed Corp.. The 510(k) number is K122627.

When did GIO DIGITAL PRESSURE GUAGES receive FDA 510(k) clearance?

GIO DIGITAL PRESSURE GUAGES received FDA 510(k) clearance on 2013-08-22, under 510(k) number K122627.

Who is the listed applicant for GIO DIGITAL PRESSURE GUAGES?

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

What is the FDA product code for GIO DIGITAL PRESSURE GUAGES?

The FDA product code for GIO DIGITAL PRESSURE GUAGES 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 Galemed 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.

K082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEK072755GALEMED CPAP MASKK022124GALEMED PEAK FLOW METER, MODELS 3751/3752K021742GALEMED NEB-EASY NEBULIZER

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.K122077MANOMETERIntersurgical, Inc.

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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