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FDA 510(k)

SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM

K-Number: K912909 · 1991-11-05

ApplicantAir-Shields Vickers, Inc.
Decision Date1991-11-05
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields Vickers, Inc.. It received FDA 510(k) clearance on 1991-11-05 under 510(k) number K912909. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM?

SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM is a medical device that received FDA 510(k) clearance on 1991-11-05. The listed applicant is Air-Shields Vickers, Inc.. The 510(k) number is K912909.

When did SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM receive FDA 510(k) clearance?

SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM received FDA 510(k) clearance on 1991-11-05, under 510(k) number K912909.

Who is the listed applicant for SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM?

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

What is the FDA product code for SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM?

The FDA product code for SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM is FMZ.

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Other records listing Air-Shields Vickers, 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.

K924679OXYCARE(TM) OXYGEN CONTROLLER/MONITORK924297DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIERK912908AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEMK912910C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEMK904691AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYSTK903378MODEL C286 ISOLETTE INFANT INCUBATOR

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Related Devices (Code: FMZ)

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.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.

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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