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)

MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV

K-Number: K962517 · 1997-02-20

ApplicantHealthdyne Technologies, Inc.
Decision Date1997-02-20
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne Technologies, Inc.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K962517. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV?

MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Healthdyne Technologies, Inc.. The 510(k) number is K962517.

When did MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV receive FDA 510(k) clearance?

MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV received FDA 510(k) clearance on 1997-02-20, under 510(k) number K962517.

Who is the listed applicant for MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV?

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

What is the FDA product code for MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV?

The FDA product code for MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV is MNS. This falls under the Neurology category.

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 Healthdyne Technologies, 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.

K983572SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500K974453NASAL INTERFACE MODEL 7910K974879MODEL 7410 VOYAGERK972614TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605K971867ALICE 4R SYSTEMK971545PROTEGE LIQUID OXYGEN SYSTEM

View all 9 devices →

Related Devices (Code: MNS)

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.

K251889myAirResmed CorpK252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical ABK231064ReddyPort ElbowSmd Manufacturing, LLCK213169BPAP SystemBMC Medical 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.

↑