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FDA 510(k)

QA-ES

K-Number: K971092 · 1997-04-23

ApplicantSmith
Decision Date1997-04-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QA-ES is the device name listed in this FDA 510(k) record. The listed applicant is Smith. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K971092. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QA-ES?

QA-ES is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Smith. The 510(k) number is K971092.

When did QA-ES receive FDA 510(k) clearance?

QA-ES received FDA 510(k) clearance on 1997-04-23, under 510(k) number K971092.

Who is the listed applicant for QA-ES?

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

What is the FDA product code for QA-ES?

The FDA product code for QA-ES is GEI.

Other records listing Smith 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.

K973747CONTROLLED TEMPERATURE CABINET SYSTEMK973748TEMPO AND TEMP H20K972123PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905K970555IL0292 DP ECHOPORT

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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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