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FDA 510(k)

MODEL 65 HIGH & LOW PRESSURE ALARM

K-Number: K780863 · 1978-08-21

ApplicantThe John Bunn Co.
Decision Date1978-08-21
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 65 HIGH & LOW PRESSURE ALARM is the device name listed in this FDA 510(k) record. The listed applicant is The John Bunn Co.. It received FDA 510(k) clearance on 1978-08-21 under 510(k) number K780863. 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 MODEL 65 HIGH & LOW PRESSURE ALARM?

MODEL 65 HIGH & LOW PRESSURE ALARM is a medical device that received FDA 510(k) clearance on 1978-08-21. The listed applicant is The John Bunn Co.. The 510(k) number is K780863.

When did MODEL 65 HIGH & LOW PRESSURE ALARM receive FDA 510(k) clearance?

MODEL 65 HIGH & LOW PRESSURE ALARM received FDA 510(k) clearance on 1978-08-21, under 510(k) number K780863.

Who is the listed applicant for MODEL 65 HIGH & LOW PRESSURE ALARM?

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

What is the FDA product code for MODEL 65 HIGH & LOW PRESSURE ALARM?

The FDA product code for MODEL 65 HIGH & LOW PRESSURE ALARM 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 The John Bunn Co. 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.

K900854JOHN BUNN: MEDIX COMPACT TRAVELLERK883216BUNN MODEL 50 OXYGEN FLOW CONTROLLERK873071BUNN CONCENTRATOR MODEL 2100 SERIESK870094BUNN MODEL 530 ASPIRATORK861435BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVEK861199BUNN MODEL 22 OXYGEN FLOW CONTROLLER

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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

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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