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FDA 510(k)

JEE FRAME (VENTILATOR CIRCUIT SUPPORT)

K-Number: K850924 · 1985-07-19

ApplicantVulcan Laboratories, Inc.
Decision Date1985-07-19
Product CodeJAY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

JEE FRAME (VENTILATOR CIRCUIT SUPPORT) is the device name listed in this FDA 510(k) record. The listed applicant is Vulcan Laboratories, Inc.. It received FDA 510(k) clearance on 1985-07-19 under 510(k) number K850924. The device is classified under product code JAY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JEE FRAME (VENTILATOR CIRCUIT SUPPORT)?

JEE FRAME (VENTILATOR CIRCUIT SUPPORT) is a medical device that received FDA 510(k) clearance on 1985-07-19. The listed applicant is Vulcan Laboratories, Inc.. The 510(k) number is K850924.

When did JEE FRAME (VENTILATOR CIRCUIT SUPPORT) receive FDA 510(k) clearance?

JEE FRAME (VENTILATOR CIRCUIT SUPPORT) received FDA 510(k) clearance on 1985-07-19, under 510(k) number K850924.

Who is the listed applicant for JEE FRAME (VENTILATOR CIRCUIT SUPPORT)?

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

What is the FDA product code for JEE FRAME (VENTILATOR CIRCUIT SUPPORT)?

The FDA product code for JEE FRAME (VENTILATOR CIRCUIT SUPPORT) is JAY.

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 Vulcan Laboratories, 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.

K851451STAT GAS MODULE

Related Devices (Code: JAY)

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.

K944988CUSTOM MEDICAL SUSPENSION STRAPCustom Medical Specialties, Inc.K873491BLOCK, BITE, INTUBATIONB&B Medical Technologies, Inc.K860583DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315Dale Medical Products, Inc.K850309COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCKAckrad LaboratoriesK840844ENDO-SECUREExidyne, Inc.K834265TRACH MATETempe Biomedical, 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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