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)

OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM

K-Number: K911770 · 1991-10-15

ApplicantAutomatic Liquid Packaging, Inc.
Decision Date1991-10-15
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Automatic Liquid Packaging, Inc.. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K911770. 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 OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM?

OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Automatic Liquid Packaging, Inc.. The 510(k) number is K911770.

When did OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM receive FDA 510(k) clearance?

OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM received FDA 510(k) clearance on 1991-10-15, under 510(k) number K911770.

Who is the listed applicant for OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM?

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

What is the FDA product code for OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM?

The FDA product code for OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM 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 Automatic Liquid Packaging, 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.

K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USPK000964STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109K980147YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTIONK973829IRRIGATION BOTTLEK962079HUMIDIFIER ADAPTERK955104HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER

View all 21 devices →

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

View on FDA Database →

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

↑