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FDA 510(k)

4004 CONSTANT FLOW REGULATOR

K-Number: K813466 · 1982-01-07

ApplicantSafety Laboratories West
Decision Date1982-01-07
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

4004 CONSTANT FLOW REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Safety Laboratories West. It received FDA 510(k) clearance on 1982-01-07 under 510(k) number K813466. 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 4004 CONSTANT FLOW REGULATOR?

4004 CONSTANT FLOW REGULATOR is a medical device that received FDA 510(k) clearance on 1982-01-07. The listed applicant is Safety Laboratories West. The 510(k) number is K813466.

When did 4004 CONSTANT FLOW REGULATOR receive FDA 510(k) clearance?

4004 CONSTANT FLOW REGULATOR received FDA 510(k) clearance on 1982-01-07, under 510(k) number K813466.

Who is the listed applicant for 4004 CONSTANT FLOW REGULATOR?

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

What is the FDA product code for 4004 CONSTANT FLOW REGULATOR?

The FDA product code for 4004 CONSTANT FLOW 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 Safety Laboratories West 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.

K8134672002 ADJUSTABLE FLOW REGULATOR

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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