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FDA 510(k)

I.V. SENTRY ALARM DEVICE

K-Number: K802101 · 1980-09-16

ApplicantPike Medical Co.
Decision Date1980-09-16
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. SENTRY ALARM DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Pike Medical Co.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K802101. 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. SENTRY ALARM DEVICE?

I.V. SENTRY ALARM DEVICE is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Pike Medical Co.. The 510(k) number is K802101.

When did I.V. SENTRY ALARM DEVICE receive FDA 510(k) clearance?

I.V. SENTRY ALARM DEVICE received FDA 510(k) clearance on 1980-09-16, under 510(k) number K802101.

Who is the listed applicant for I.V. SENTRY ALARM DEVICE?

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

What is the FDA product code for I.V. SENTRY ALARM DEVICE?

The FDA product code for I.V. SENTRY ALARM DEVICE is FLN.

Related Clinical Trials

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.

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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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