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FDA 510(k)

PENLON BREATHING SYSTEM PRESSURE MONITOR

K-Number: K902381 · 1990-08-17

ApplicantPenlon, Inc.
Decision Date1990-08-17
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PENLON BREATHING SYSTEM PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Penlon, Inc.. It received FDA 510(k) clearance on 1990-08-17 under 510(k) number K902381. 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 PENLON BREATHING SYSTEM PRESSURE MONITOR?

PENLON BREATHING SYSTEM PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1990-08-17. The listed applicant is Penlon, Inc.. The 510(k) number is K902381.

When did PENLON BREATHING SYSTEM PRESSURE MONITOR receive FDA 510(k) clearance?

PENLON BREATHING SYSTEM PRESSURE MONITOR received FDA 510(k) clearance on 1990-08-17, under 510(k) number K902381.

Who is the listed applicant for PENLON BREATHING SYSTEM PRESSURE MONITOR?

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

What is the FDA product code for PENLON BREATHING SYSTEM PRESSURE MONITOR?

The FDA product code for PENLON BREATHING SYSTEM PRESSURE 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 Penlon, Inc. 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.

K936046SIGMA ELITEK894689PENLON IDP PRESSURE FAILURE ALARMK844008PENLON AM1000 ANAESTHESIA MACHINEK844007PENLON PPV VAPORIZERK823555MAGTARAK RESPIRATORY MONITOR & FLOW SENSK803052NUFFIELD ANESTHESIA VENTILATOR SER. 400

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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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