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FDA 510(k)

SOREX SAFE-AIR

K-Number: K911150 · 1991-06-28

ApplicantSorex Medical
Decision Date1991-06-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOREX SAFE-AIR is the device name listed in this FDA 510(k) record. The listed applicant is Sorex Medical. It received FDA 510(k) clearance on 1991-06-28 under 510(k) number K911150. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOREX SAFE-AIR?

SOREX SAFE-AIR is a medical device that received FDA 510(k) clearance on 1991-06-28. The listed applicant is Sorex Medical. The 510(k) number is K911150.

When did SOREX SAFE-AIR receive FDA 510(k) clearance?

SOREX SAFE-AIR received FDA 510(k) clearance on 1991-06-28, under 510(k) number K911150.

Who is the listed applicant for SOREX SAFE-AIR?

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

What is the FDA product code for SOREX SAFE-AIR?

The FDA product code for SOREX SAFE-AIR is GEX. This falls under the Gastroenterology category.

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Other records listing Sorex Medical 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.

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Related Devices (Code: GEX)

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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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