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FDA 510(k)

PRESSURE REGULATOR

K-Number: K853039 · 1986-04-11

ApplicantErie Medical
Decision Date1986-04-11
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRESSURE REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Erie Medical. It received FDA 510(k) clearance on 1986-04-11 under 510(k) number K853039. The device is classified under product code CAN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE REGULATOR?

PRESSURE REGULATOR is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Erie Medical. The 510(k) number is K853039.

When did PRESSURE REGULATOR receive FDA 510(k) clearance?

PRESSURE REGULATOR received FDA 510(k) clearance on 1986-04-11, under 510(k) number K853039.

Who is the listed applicant for PRESSURE REGULATOR?

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

What is the FDA product code for PRESSURE REGULATOR?

The FDA product code for PRESSURE REGULATOR is CAN.

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 Erie Medical 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.

K861865ERIE-NEBK853051TRACHEAL TUBESK853040PRESSURE GAUGEK832466TRACHEAL TUBE 16 GAUGE-1.65MM-

Related Devices (Code: CAN)

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.

K162811MR Conditional CGA 870Essex Industries, Inc.K080243PORTABLE OXYGEN UNIT SCA900San Cheong Co. , Ltd.K060265REMCORE REMOTE CONTROLLED OXYGEN REGULATORRemcore, Inc.K061785CYL-FIL OXYGEN SYSTEMResponsive Respiratory, Inc.K950777OXYGEN REGULATORMada Medical Products, Inc.K942751VANGUARD SERIES GAS REGULATORSBuckman Co., Inc.

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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