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FDA 510(k)

ADEL - MODEL 986 INFANT WARMER

K-Number: K890476 · 1989-06-16

ApplicantAdel Medical , Ltd.
Decision Date1989-06-16
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ADEL - MODEL 986 INFANT WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Adel Medical , Ltd.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K890476. 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 ADEL - MODEL 986 INFANT WARMER?

ADEL - MODEL 986 INFANT WARMER is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Adel Medical , Ltd.. The 510(k) number is K890476.

When did ADEL - MODEL 986 INFANT WARMER receive FDA 510(k) clearance?

ADEL - MODEL 986 INFANT WARMER received FDA 510(k) clearance on 1989-06-16, under 510(k) number K890476.

Who is the listed applicant for ADEL - MODEL 986 INFANT WARMER?

The FDA 510(k) record lists Adel Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADEL - MODEL 986 INFANT WARMER?

The FDA product code for ADEL - MODEL 986 INFANT WARMER is FMZ.

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Other records listing Adel Medical , Ltd. 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.

K874610ADEL MODEL 2100 BIRTHING BEDK871475SOLOLIFT - PATIENT TRANSFER STRETCHERK861030LABOR-DELIVERY STRETCH/BEDK860020MINOR SURGERY LIGHT MODEL 2112K833321LABOR/DELIVERY/RECOVERY BED LDR-600K810886ADEL MEDICAL BIRTHING BED, #LD-500

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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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