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FDA 510(k)

ALERT

K-Number: K974131 · 1997-12-17

ApplicantJeneric/Pentron, Inc.
Decision Date1997-12-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1997-12-17 under 510(k) number K974131. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALERT?

ALERT is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K974131.

When did ALERT receive FDA 510(k) clearance?

ALERT received FDA 510(k) clearance on 1997-12-17, under 510(k) number K974131.

Who is the listed applicant for ALERT?

The FDA 510(k) record lists Jeneric/Pentron, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALERT?

The FDA product code for ALERT is EBF.

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Other records listing Jeneric/Pentron, Inc. as applicant

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Related Devices (Code: EBF)

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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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