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FDA 510(k)

DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER

K-Number: K924297 · 1993-03-18

ApplicantAir-Shields Vickers, Inc.
Decision Date1993-03-18
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER 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 1993-03-18 under 510(k) number K924297. 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 DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER?

DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1993-03-18. The listed applicant is Air-Shields Vickers, Inc.. The 510(k) number is K924297.

When did DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER receive FDA 510(k) clearance?

DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER received FDA 510(k) clearance on 1993-03-18, under 510(k) number K924297.

Who is the listed applicant for DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER?

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 DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER?

The FDA product code for DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER 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/MONITORK912908AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEMK912909SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARMK912910C100 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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