FDA 510(k)

RESUSCITATION UNIT 105

K-Number: K103317 · 2011-04-20

Decision Date2011-04-20

Product CodeBZR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

RESUSCITATION UNIT 105 is the device name listed in this FDA 510(k) record. The listed applicant is Atom Medical Corporation. It received FDA 510(k) clearance on 2011-04-20 under 510(k) number K103317. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESUSCITATION UNIT 105?

RESUSCITATION UNIT 105 is a medical device that received FDA 510(k) clearance on 2011-04-20. The listed applicant is Atom Medical Corporation. The 510(k) number is K103317.

When did RESUSCITATION UNIT 105 receive FDA 510(k) clearance?

RESUSCITATION UNIT 105 received FDA 510(k) clearance on 2011-04-20, under 510(k) number K103317.

Who is the listed applicant for RESUSCITATION UNIT 105?

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

What is the FDA product code for RESUSCITATION UNIT 105?

The FDA product code for RESUSCITATION UNIT 105 is BZR.

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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.