Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODEL C286 ISOLETTE INFANT INCUBATOR

K-Number: K903378 · 1990-10-15

ApplicantAir-Shields Vickers, Inc.
Decision Date1990-10-15
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL C286 ISOLETTE INFANT INCUBATOR 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 1990-10-15 under 510(k) number K903378. 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 MODEL C286 ISOLETTE INFANT INCUBATOR?

MODEL C286 ISOLETTE INFANT INCUBATOR is a medical device that received FDA 510(k) clearance on 1990-10-15. The listed applicant is Air-Shields Vickers, Inc.. The 510(k) number is K903378.

When did MODEL C286 ISOLETTE INFANT INCUBATOR receive FDA 510(k) clearance?

MODEL C286 ISOLETTE INFANT INCUBATOR received FDA 510(k) clearance on 1990-10-15, under 510(k) number K903378.

Who is the listed applicant for MODEL C286 ISOLETTE INFANT INCUBATOR?

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 MODEL C286 ISOLETTE INFANT INCUBATOR?

The FDA product code for MODEL C286 ISOLETTE INFANT INCUBATOR is FMZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 9 devices →

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.

↑