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FDA 510(k)

AMETHERM

K-Number: K840526 · 1984-04-30

ApplicantEgnell, Inc.
Decision Date1984-04-30
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMETHERM is the device name listed in this FDA 510(k) record. The listed applicant is Egnell, Inc.. It received FDA 510(k) clearance on 1984-04-30 under 510(k) number K840526. 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 AMETHERM?

AMETHERM is a medical device that received FDA 510(k) clearance on 1984-04-30. The listed applicant is Egnell, Inc.. The 510(k) number is K840526.

When did AMETHERM receive FDA 510(k) clearance?

AMETHERM received FDA 510(k) clearance on 1984-04-30, under 510(k) number K840526.

Who is the listed applicant for AMETHERM?

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

What is the FDA product code for AMETHERM?

The FDA product code for AMETHERM is FMZ.

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Other records listing Egnell, 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.

K853909EGNELL UNIVERSAL SUCTION PUMPK853917EGNELL COMPACT SUCTION PUMPK844307EGNELL-LACT B BATTERY-OPERATED BREAST PUMPK834335AMEDA PHOTOTHERAPY LAMP FOR NEWBORNK832637AMEDA NEONATAL RESUSCITATION UNIT-K813312UNIVERSAL SUCTION PUMP TYPE EUS

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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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