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FDA 510(k)

MODEL C386 ISOLETTE(R) INFANT INCUBATOR

K-Number: K913291 · 1991-11-13

ApplicantAir-Shields, Inc.
Decision Date1991-11-13
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL C386 ISOLETTE(R) INFANT INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1991-11-13 under 510(k) number K913291. 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 C386 ISOLETTE(R) INFANT INCUBATOR?

MODEL C386 ISOLETTE(R) INFANT INCUBATOR is a medical device that received FDA 510(k) clearance on 1991-11-13. The listed applicant is Air-Shields, Inc.. The 510(k) number is K913291.

When did MODEL C386 ISOLETTE(R) INFANT INCUBATOR receive FDA 510(k) clearance?

MODEL C386 ISOLETTE(R) INFANT INCUBATOR received FDA 510(k) clearance on 1991-11-13, under 510(k) number K913291.

Who is the listed applicant for MODEL C386 ISOLETTE(R) INFANT INCUBATOR?

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

What is the FDA product code for MODEL C386 ISOLETTE(R) INFANT INCUBATOR?

The FDA product code for MODEL C386 ISOLETTE(R) INFANT INCUBATOR is FMZ.

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Other records listing Air-Shields, Inc. as applicant

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K974248WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEMK972309JM-102 JAUNDICE METERK971256DUO-LITE PHOTOTHERAPY SYSTEMK960980ISOLETTE INFANT INCUBATORK924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEK940951RW RESUCITAIRE INFANT RADIANT WARMER

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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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