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FDA 510(k)

Laboratorios Biogalenic Sterile Water for Inhalation, USP

K-Number: K242717 · 2025-01-30

ApplicantLaboratorios Biogalenic S.A. DE C.V.
Decision Date2025-01-30
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Laboratorios Biogalenic Sterile Water for Inhalation, USP is the device name listed in this FDA 510(k) record. The listed applicant is Laboratorios Biogalenic S.A. DE C.V.. It received FDA 510(k) clearance on 2025-01-30 under 510(k) number K242717. 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 Laboratorios Biogalenic Sterile Water for Inhalation, USP?

Laboratorios Biogalenic Sterile Water for Inhalation, USP is a medical device that received FDA 510(k) clearance on 2025-01-30. The listed applicant is Laboratorios Biogalenic S.A. DE C.V.. The 510(k) number is K242717.

When did Laboratorios Biogalenic Sterile Water for Inhalation, USP receive FDA 510(k) clearance?

Laboratorios Biogalenic Sterile Water for Inhalation, USP received FDA 510(k) clearance on 2025-01-30, under 510(k) number K242717.

Who is the listed applicant for Laboratorios Biogalenic Sterile Water for Inhalation, USP?

The FDA 510(k) record lists Laboratorios Biogalenic S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laboratorios Biogalenic Sterile Water for Inhalation, USP?

The FDA product code for Laboratorios Biogalenic Sterile Water for Inhalation, USP is BTT.

Other records listing Laboratorios Biogalenic S.A. DE C.V. 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.

K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPK243001Sterile Water USP and Sterile 0.9% Normal Saline USP

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.

K254078HVT 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, LPK251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)Fisher & Paykel Healthcare, 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.

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