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FDA 510(k)

PREFILLED STERILE WATER FOR INHALATION, USP

K-Number: K871618 · 1987-05-08

ApplicantAutomatic Liquid Packaging, Inc.
Decision Date1987-05-08
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREFILLED STERILE WATER FOR INHALATION, USP 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 1987-05-08 under 510(k) number K871618. 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 PREFILLED STERILE WATER FOR INHALATION, USP?

PREFILLED STERILE WATER FOR INHALATION, USP is a medical device that received FDA 510(k) clearance on 1987-05-08. The listed applicant is Automatic Liquid Packaging, Inc.. The 510(k) number is K871618.

When did PREFILLED STERILE WATER FOR INHALATION, USP receive FDA 510(k) clearance?

PREFILLED STERILE WATER FOR INHALATION, USP received FDA 510(k) clearance on 1987-05-08, under 510(k) number K871618.

Who is the listed applicant for PREFILLED STERILE WATER FOR INHALATION, USP?

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 PREFILLED STERILE WATER FOR INHALATION, USP?

The FDA product code for PREFILLED STERILE WATER FOR INHALATION, USP is BTT.

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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

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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.

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