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FDA 510(k)

INTERTECH STERILE WATER FOR INHALATION

K-Number: K881184 · 1988-05-25

ApplicantDelmed, Inc.
Decision Date1988-05-25
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTERTECH STERILE WATER FOR INHALATION is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1988-05-25 under 510(k) number K881184. 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 INTERTECH STERILE WATER FOR INHALATION?

INTERTECH STERILE WATER FOR INHALATION is a medical device that received FDA 510(k) clearance on 1988-05-25. The listed applicant is Delmed, Inc.. The 510(k) number is K881184.

When did INTERTECH STERILE WATER FOR INHALATION receive FDA 510(k) clearance?

INTERTECH STERILE WATER FOR INHALATION received FDA 510(k) clearance on 1988-05-25, under 510(k) number K881184.

Who is the listed applicant for INTERTECH STERILE WATER FOR INHALATION?

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

What is the FDA product code for INTERTECH STERILE WATER FOR INHALATION?

The FDA product code for INTERTECH STERILE WATER FOR INHALATION is BTT.

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Other records listing Delmed, Inc. as applicant

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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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