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FDA 510(k)

STERILIZATION OF DEVICES BY RADIATION

K-Number: K874659 · 1988-02-02

ApplicantInhalation Plastics
Decision Date1988-02-02
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STERILIZATION OF DEVICES BY RADIATION is the device name listed in this FDA 510(k) record. The listed applicant is Inhalation Plastics. It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K874659. 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 STERILIZATION OF DEVICES BY RADIATION?

STERILIZATION OF DEVICES BY RADIATION is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Inhalation Plastics. The 510(k) number is K874659.

When did STERILIZATION OF DEVICES BY RADIATION receive FDA 510(k) clearance?

STERILIZATION OF DEVICES BY RADIATION received FDA 510(k) clearance on 1988-02-02, under 510(k) number K874659.

Who is the listed applicant for STERILIZATION OF DEVICES BY RADIATION?

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

What is the FDA product code for STERILIZATION OF DEVICES BY RADIATION?

The FDA product code for STERILIZATION OF DEVICES BY RADIATION is BTT.

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Other records listing Inhalation Plastics 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.

K945565SPIRO-FLEXK914686THERMO-FLOW SETK901315AEROMIST II NEBULIZERK900990FILT-R-ALL BACTERIAL/VIRAL FILTERK900594ANESTHESIA BREATHING CIRCUITK896832FILT-R-ALL BACTERIAL FILTER

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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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