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)

PORTABLE LIFECARE VENTILATOR PLV-100

K-Number: K832467 · 1983-10-20

ApplicantLifecare Services, Inc.
Decision Date1983-10-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE LIFECARE VENTILATOR PLV-100 is the device name listed in this FDA 510(k) record. The listed applicant is Lifecare Services, Inc.. It received FDA 510(k) clearance on 1983-10-20 under 510(k) number K832467. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE LIFECARE VENTILATOR PLV-100?

PORTABLE LIFECARE VENTILATOR PLV-100 is a medical device that received FDA 510(k) clearance on 1983-10-20. The listed applicant is Lifecare Services, Inc.. The 510(k) number is K832467.

When did PORTABLE LIFECARE VENTILATOR PLV-100 receive FDA 510(k) clearance?

PORTABLE LIFECARE VENTILATOR PLV-100 received FDA 510(k) clearance on 1983-10-20, under 510(k) number K832467.

Who is the listed applicant for PORTABLE LIFECARE VENTILATOR PLV-100?

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

What is the FDA product code for PORTABLE LIFECARE VENTILATOR PLV-100?

The FDA product code for PORTABLE LIFECARE VENTILATOR PLV-100 is CBK.

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 Lifecare Services, 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.

K913423LIFECARE REMOTE ALARM IIK912224LIFECARE CPAP-100K910947NEV-10 NEGATIVE PRESSURE VENTILATORK894779LIFECARE NASAL MASK KIT CAT. NO. 06-800K895592FREEWAY NEBULIZER COMPRESSORK894361LIFECARE PRESSURE ALARM CAT. NO. 34-010

View all 20 devices →

Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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.

↑