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FDA 510(k)

INFUSSION ALARM SYSTEM I.A.S. CAT.#1118

K-Number: K802011 · 1980-10-31

ApplicantPollak (Intl.), Ltd.
Decision Date1980-10-31
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 is the device name listed in this FDA 510(k) record. The listed applicant is Pollak (Intl.), Ltd.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802011. The device is classified under product code FLN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUSSION ALARM SYSTEM I.A.S. CAT.#1118?

INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Pollak (Intl.), Ltd.. The 510(k) number is K802011.

When did INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 receive FDA 510(k) clearance?

INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802011.

Who is the listed applicant for INFUSSION ALARM SYSTEM I.A.S. CAT.#1118?

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

What is the FDA product code for INFUSSION ALARM SYSTEM I.A.S. CAT.#1118?

The FDA product code for INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 is FLN.

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Other records listing Pollak (Intl.), Ltd. 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.

K000227UMBICUTK810049PEDICAT*K810050VECAFIX*K802009FLOWCLAMP CAT.#1011 & 1012K802017DRESSING CHANGE SET CAT.#910-930K802007PEDIWET=GUAZE IMPREGNATED WITH PETROL

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Related Devices (Code: FLN)

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.

K172242DripAssist PlusShift Labs, Inc.K080704LOW FLUID ALARMEm-Tec GmbHK050783ISSYS DRUG FLOW MONITORIntegrated Sensing Systems, Inc.K060123LEVELERT II FLUID LEVEL SENSORSmith & Nephew, Inc.K030136DRIP ALERTDrip Alert, Inc.K022248STRYKER L3 HYDROLERTStryker Endoscopy

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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