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FDA 510(k)

CLEAN AIR

K-Number: K943201 · 1995-02-28

ApplicantWallach Surgical Devices, Inc.
Decision Date1995-02-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLEAN AIR is the device name listed in this FDA 510(k) record. The listed applicant is Wallach Surgical Devices, Inc.. It received FDA 510(k) clearance on 1995-02-28 under 510(k) number K943201. 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 CLEAN AIR?

CLEAN AIR is a medical device that received FDA 510(k) clearance on 1995-02-28. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K943201.

When did CLEAN AIR receive FDA 510(k) clearance?

CLEAN AIR received FDA 510(k) clearance on 1995-02-28, under 510(k) number K943201.

Who is the listed applicant for CLEAN AIR?

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

What is the FDA product code for CLEAN AIR?

The FDA product code for CLEAN AIR is GEX. This falls under the Gastroenterology category.

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Other records listing Wallach Surgical Devices, Inc. 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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