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FDA 510(k)

INTRA-ALERT

K-Number: K781297 · 1978-10-25

ApplicantPan-Tech Research, Inc.
Decision Date1978-10-25
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTRA-ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Pan-Tech Research, Inc.. It received FDA 510(k) clearance on 1978-10-25 under 510(k) number K781297. 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 INTRA-ALERT?

INTRA-ALERT is a medical device that received FDA 510(k) clearance on 1978-10-25. The listed applicant is Pan-Tech Research, Inc.. The 510(k) number is K781297.

When did INTRA-ALERT receive FDA 510(k) clearance?

INTRA-ALERT received FDA 510(k) clearance on 1978-10-25, under 510(k) number K781297.

Who is the listed applicant for INTRA-ALERT?

The FDA 510(k) record lists Pan-Tech Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRA-ALERT?

The FDA product code for INTRA-ALERT 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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Other records listing Pan-Tech Research, Inc. 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.

K820759VEIN-SHIELD

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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