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FDA 510(k)

ISOLETTE INCUBATOR

K-Number: K781876 · 1978-12-07

ApplicantAir-Shields, Inc.
Decision Date1978-12-07
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISOLETTE 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 1978-12-07 under 510(k) number K781876. 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 ISOLETTE INCUBATOR?

ISOLETTE INCUBATOR is a medical device that received FDA 510(k) clearance on 1978-12-07. The listed applicant is Air-Shields, Inc.. The 510(k) number is K781876.

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

ISOLETTE INCUBATOR received FDA 510(k) clearance on 1978-12-07, under 510(k) number K781876.

Who is the listed applicant for ISOLETTE 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 ISOLETTE INCUBATOR?

The FDA product code for ISOLETTE INCUBATOR is FMZ.

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Other records listing Air-Shields, 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.

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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