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FDA 510(k)

ACU-ALERT

K-Number: K791399 · 1979-10-11

ApplicantAcumed Instruments Corp.
Decision Date1979-10-11
Product Code
DecisionSubstantially Equivalent

Device Summary

ACU-ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Acumed Instruments Corp.. It received FDA 510(k) clearance on 1979-10-11 under 510(k) number K791399. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU-ALERT?

ACU-ALERT is a medical device that received FDA 510(k) clearance on 1979-10-11. The listed applicant is Acumed Instruments Corp.. The 510(k) number is K791399.

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

ACU-ALERT received FDA 510(k) clearance on 1979-10-11, under 510(k) number K791399.

Who is the listed applicant for ACU-ALERT?

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

Related Clinical Trials

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Other records listing Acumed Instruments Corp. 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.

K863627MICRO SURGICAL DRILL SYSTEMK853659POWERED IRRIGATION FOR MICRO SURGICAL DRILLK853660MICRO SURGICAL DRILL SYSTEMK853658BURS FOR MICRO SURGICAL DRILL SYSTEMK791891ACU-MED RED MISER HEMOTHORAX BLOOD COLL.K791400GASTRIC LAVAGE KIT-DISPOSABLE

View all 8 devices →

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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