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FDA 510(k)

NEONATAL HEATED HUMIDIFIER

K-Number: K792620 · 1980-01-24

ApplicantModern Medical Systems Co.
Decision Date1980-01-24
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEONATAL HEATED HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Systems Co.. It received FDA 510(k) clearance on 1980-01-24 under 510(k) number K792620. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL HEATED HUMIDIFIER?

NEONATAL HEATED HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1980-01-24. The listed applicant is Modern Medical Systems Co.. The 510(k) number is K792620.

When did NEONATAL HEATED HUMIDIFIER receive FDA 510(k) clearance?

NEONATAL HEATED HUMIDIFIER received FDA 510(k) clearance on 1980-01-24, under 510(k) number K792620.

Who is the listed applicant for NEONATAL HEATED HUMIDIFIER?

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

What is the FDA product code for NEONATAL HEATED HUMIDIFIER?

The FDA product code for NEONATAL HEATED HUMIDIFIER is BTT.

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 Modern Medical Systems Co. 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.

K802081AULD BAGGER KIT

Related Devices (Code: BTT)

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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