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FDA 510(k)

STANDEX

K-Number: K885343 · 1989-05-01

ApplicantAlt, Inc.
Decision Date1989-05-01
Product CodeION
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STANDEX is the device name listed in this FDA 510(k) record. The listed applicant is Alt, Inc.. It received FDA 510(k) clearance on 1989-05-01 under 510(k) number K885343. The device is classified under product code ION. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANDEX?

STANDEX is a medical device that received FDA 510(k) clearance on 1989-05-01. The listed applicant is Alt, Inc.. The 510(k) number is K885343.

When did STANDEX receive FDA 510(k) clearance?

STANDEX received FDA 510(k) clearance on 1989-05-01, under 510(k) number K885343.

Who is the listed applicant for STANDEX?

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

What is the FDA product code for STANDEX?

The FDA product code for STANDEX is ION.

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Related Devices (Code: ION)

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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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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