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FDA 510(k)

ISOLATION MASK I.C.S.

K-Number: K831062 · 1983-04-13

ApplicantAmerican Threshold Industries, Inc.
Decision Date1983-04-13
Product CodeLGM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISOLATION MASK I.C.S. is the device name listed in this FDA 510(k) record. The listed applicant is American Threshold Industries, Inc.. It received FDA 510(k) clearance on 1983-04-13 under 510(k) number K831062. The device is classified under product code LGM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLATION MASK I.C.S.?

ISOLATION MASK I.C.S. is a medical device that received FDA 510(k) clearance on 1983-04-13. The listed applicant is American Threshold Industries, Inc.. The 510(k) number is K831062.

When did ISOLATION MASK I.C.S. receive FDA 510(k) clearance?

ISOLATION MASK I.C.S. received FDA 510(k) clearance on 1983-04-13, under 510(k) number K831062.

Who is the listed applicant for ISOLATION MASK I.C.S.?

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

What is the FDA product code for ISOLATION MASK I.C.S.?

The FDA product code for ISOLATION MASK I.C.S. is LGM.

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Other records listing American Threshold Industries, 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.

K971483SECURE-WRAP (TM) STERILIZATION WRAPK953879SURGEON'S CAPK953878BOUFFANT CAPK952115BARRIER GOWN, KOOL-GARD BACKLESS GOWNK952114KOOL GARD SINGLES GOWNK952116COVER GOWN

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Related Devices (Code: LGM)

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.

K231256Carecube Negative Pressure Isolation ChamberCarecubes, Inc.K163223ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLCK080117PATIENT ISOLATION UNIT, MODEL G019-1000Gentex CorporationK022260FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMSIsolation Systems, Inc.K944133MTB 1043 TREATMENT BOOTHMark Solutions, Inc.K912444MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEMRadiometer America, 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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