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FDA 510(k)

MODEL AS* 7B AUTOSYRINGE INFUSION PUMP

K-Number: K802166 · 1980-11-12

ApplicantBaxter Healthcare Corp
Decision Date1980-11-12
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL AS* 7B AUTOSYRINGE INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802166. 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 MODEL AS* 7B AUTOSYRINGE INFUSION PUMP?

MODEL AS* 7B AUTOSYRINGE INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K802166.

When did MODEL AS* 7B AUTOSYRINGE INFUSION PUMP receive FDA 510(k) clearance?

MODEL AS* 7B AUTOSYRINGE INFUSION PUMP received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802166.

Who is the listed applicant for MODEL AS* 7B AUTOSYRINGE INFUSION PUMP?

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

What is the FDA product code for MODEL AS* 7B AUTOSYRINGE INFUSION PUMP?

The FDA product code for MODEL AS* 7B AUTOSYRINGE INFUSION PUMP is FLN.

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Other records listing Baxter Healthcare Corp as applicant

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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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