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FDA 510(k)

ISOLAIR 2 FULL FACE SPLASH GUARD

K-Number: K931288 · 1994-01-21

ApplicantLouis M. Gerson Co., Inc.
Decision Date1994-01-21
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLAIR 2 FULL FACE SPLASH GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Louis M. Gerson Co., Inc.. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K931288. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLAIR 2 FULL FACE SPLASH GUARD?

ISOLAIR 2 FULL FACE SPLASH GUARD is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Louis M. Gerson Co., Inc.. The 510(k) number is K931288.

When did ISOLAIR 2 FULL FACE SPLASH GUARD receive FDA 510(k) clearance?

ISOLAIR 2 FULL FACE SPLASH GUARD received FDA 510(k) clearance on 1994-01-21, under 510(k) number K931288.

Who is the listed applicant for ISOLAIR 2 FULL FACE SPLASH GUARD?

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

What is the FDA product code for ISOLAIR 2 FULL FACE SPLASH GUARD?

The FDA product code for ISOLAIR 2 FULL FACE SPLASH GUARD is LYU.

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Other records listing Louis M. Gerson Co., 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.

K061375RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730K050193GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATORK960778ISOLAIR APR TYPE N95K925185ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MASK922507GERSON ISOLAIR APR PARTICULATE SURGICAL MASKK881910LABELING CHANGE TO SURGICAL FACE MASK

View all 8 devices →

Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., Inc.

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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