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FDA 510(k)

NEONATAL RESUSCITATOR, SAMSON

K-Number: K761065 · 1977-01-26

ApplicantDem Medical, Inc.
Decision Date1977-01-26
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEONATAL RESUSCITATOR, SAMSON is the device name listed in this FDA 510(k) record. The listed applicant is Dem Medical, Inc.. It received FDA 510(k) clearance on 1977-01-26 under 510(k) number K761065. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL RESUSCITATOR, SAMSON?

NEONATAL RESUSCITATOR, SAMSON is a medical device that received FDA 510(k) clearance on 1977-01-26. The listed applicant is Dem Medical, Inc.. The 510(k) number is K761065.

When did NEONATAL RESUSCITATOR, SAMSON receive FDA 510(k) clearance?

NEONATAL RESUSCITATOR, SAMSON received FDA 510(k) clearance on 1977-01-26, under 510(k) number K761065.

Who is the listed applicant for NEONATAL RESUSCITATOR, SAMSON?

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

What is the FDA product code for NEONATAL RESUSCITATOR, SAMSON?

The FDA product code for NEONATAL RESUSCITATOR, SAMSON is BTM.

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Related Devices (Code: BTM)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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