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FDA 510(k)

ANAGO ISOLATION MASK (#80-950)

K-Number: K864116 · 1986-11-25

ApplicantAnago, Inc.
Decision Date1986-11-25
Product CodeLGM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ANAGO ISOLATION MASK (#80-950) is the device name listed in this FDA 510(k) record. The listed applicant is Anago, Inc.. It received FDA 510(k) clearance on 1986-11-25 under 510(k) number K864116. 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 ANAGO ISOLATION MASK (#80-950)?

ANAGO ISOLATION MASK (#80-950) is a medical device that received FDA 510(k) clearance on 1986-11-25. The listed applicant is Anago, Inc.. The 510(k) number is K864116.

When did ANAGO ISOLATION MASK (#80-950) receive FDA 510(k) clearance?

ANAGO ISOLATION MASK (#80-950) received FDA 510(k) clearance on 1986-11-25, under 510(k) number K864116.

Who is the listed applicant for ANAGO ISOLATION MASK (#80-950)?

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

What is the FDA product code for ANAGO ISOLATION MASK (#80-950)?

The FDA product code for ANAGO ISOLATION MASK (#80-950) is LGM.

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Other records listing Anago, 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.

K925659U.C.E.Z. LENS CLEANER KITK930161ANAGO SPINAL ANESTHESIA TRAYK926590ANAGO DISPOSABLE INSTANT COLD PACKK926137ANAGO FEM-COOL/FEM-COOL PETITEK926589ANAGO WARM PACKK920615ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT

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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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