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FDA 510(k)

PREFILLED HUMIDIFER

K-Number: K810219 · 1981-03-04

ApplicantCorpak Co.
Decision Date1981-03-04
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREFILLED HUMIDIFER is the device name listed in this FDA 510(k) record. The listed applicant is Corpak Co.. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K810219. 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 HUMIDIFER?

PREFILLED HUMIDIFER is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Corpak Co.. The 510(k) number is K810219.

When did PREFILLED HUMIDIFER receive FDA 510(k) clearance?

PREFILLED HUMIDIFER received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810219.

Who is the listed applicant for PREFILLED HUMIDIFER?

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

What is the FDA product code for PREFILLED HUMIDIFER?

The FDA product code for PREFILLED HUMIDIFER is BTT.

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Other records listing Corpak Co. 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.

K935512CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACOREK931921CORPAK GASTROSTOMY TUBEK932847CORPAK ENTERAL PUMPK902949CORPAK GRASPING FORCEPSK901501CORPAK GASTROSTOMY TUBEK882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE

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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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