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FDA 510(k)

AMEDA NEONATAL RESUSCITATION UNIT-

K-Number: K832637 · 1983-12-22

ApplicantEgnell, Inc.
Decision Date1983-12-22
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMEDA NEONATAL RESUSCITATION UNIT- is the device name listed in this FDA 510(k) record. The listed applicant is Egnell, Inc.. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K832637. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDA NEONATAL RESUSCITATION UNIT-?

AMEDA NEONATAL RESUSCITATION UNIT- is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Egnell, Inc.. The 510(k) number is K832637.

When did AMEDA NEONATAL RESUSCITATION UNIT- receive FDA 510(k) clearance?

AMEDA NEONATAL RESUSCITATION UNIT- received FDA 510(k) clearance on 1983-12-22, under 510(k) number K832637.

Who is the listed applicant for AMEDA NEONATAL RESUSCITATION UNIT-?

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 AMEDA NEONATAL RESUSCITATION UNIT-?

The FDA product code for AMEDA NEONATAL RESUSCITATION UNIT- is FMT.

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Other records listing Egnell, Inc. as applicant

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Related Devices (Code: FMT)

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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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