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FDA 510(k)

I.V. SENTINEL

K-Number: K821823 · 1982-08-16

ApplicantThe John Bunn Co.
Decision Date1982-08-16
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. SENTINEL is the device name listed in this FDA 510(k) record. The listed applicant is The John Bunn Co.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K821823. 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 I.V. SENTINEL?

I.V. SENTINEL is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is The John Bunn Co.. The 510(k) number is K821823.

When did I.V. SENTINEL receive FDA 510(k) clearance?

I.V. SENTINEL received FDA 510(k) clearance on 1982-08-16, under 510(k) number K821823.

Who is the listed applicant for I.V. SENTINEL?

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

What is the FDA product code for I.V. SENTINEL?

The FDA product code for I.V. SENTINEL is FLN.

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Other records listing The John Bunn 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.

K900854JOHN BUNN: MEDIX COMPACT TRAVELLERK883216BUNN MODEL 50 OXYGEN FLOW CONTROLLERK873071BUNN CONCENTRATOR MODEL 2100 SERIESK870094BUNN MODEL 530 ASPIRATORK861435BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVEK861199BUNN MODEL 22 OXYGEN FLOW CONTROLLER

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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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