Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LAKEVILLE BODY VENTILATOR

K-Number: K840885 · 1984-07-12

ApplicantEdwards Ventilator Co.
Decision Date1984-07-12
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LAKEVILLE BODY VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Ventilator Co.. It received FDA 510(k) clearance on 1984-07-12 under 510(k) number K840885. The device is classified under product code BYT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAKEVILLE BODY VENTILATOR?

LAKEVILLE BODY VENTILATOR is a medical device that received FDA 510(k) clearance on 1984-07-12. The listed applicant is Edwards Ventilator Co.. The 510(k) number is K840885.

When did LAKEVILLE BODY VENTILATOR receive FDA 510(k) clearance?

LAKEVILLE BODY VENTILATOR received FDA 510(k) clearance on 1984-07-12, under 510(k) number K840885.

Who is the listed applicant for LAKEVILLE BODY VENTILATOR?

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

What is the FDA product code for LAKEVILLE BODY VENTILATOR?

The FDA product code for LAKEVILLE BODY VENTILATOR is BYT.

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

Related Devices (Code: BYT)

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.

K082657RTX RESPIRATORMedivent LimitedK072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSDima Italia SrlK924341HAYEK OSCILLATOR(TM)Respironics, Inc.K910947NEV-10 NEGATIVE PRESSURE VENTILATORLifecare Services, Inc.K905530PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMPuritan Bennett Corp.K902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMJ. H. Emerson Co.

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.

↑