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FDA 510(k)

NEONATAL INCUBATOR (ACCESSORY)

K-Number: K895782 · 1989-12-07

ApplicantAir-Shields Vickers, Inc.
Decision Date1989-12-07
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEONATAL INCUBATOR (ACCESSORY) 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 1989-12-07 under 510(k) number K895782. 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 NEONATAL INCUBATOR (ACCESSORY)?

NEONATAL INCUBATOR (ACCESSORY) is a medical device that received FDA 510(k) clearance on 1989-12-07. The listed applicant is Air-Shields Vickers, Inc.. The 510(k) number is K895782.

When did NEONATAL INCUBATOR (ACCESSORY) receive FDA 510(k) clearance?

NEONATAL INCUBATOR (ACCESSORY) received FDA 510(k) clearance on 1989-12-07, under 510(k) number K895782.

Who is the listed applicant for NEONATAL INCUBATOR (ACCESSORY)?

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 NEONATAL INCUBATOR (ACCESSORY)?

The FDA product code for NEONATAL INCUBATOR (ACCESSORY) 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 SYSTEMK912909SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARMK912910C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEMK904691AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST

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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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