FDA 510(k)

MERLIN RESUSCITATOR

K-Number: K031395 · 2004-07-16

Decision Date2004-07-16

Product CodeBTM

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MERLIN RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Merlin Medical Limited. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K031395. 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 MERLIN RESUSCITATOR?

MERLIN RESUSCITATOR is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Merlin Medical Limited. The 510(k) number is K031395.

When did MERLIN RESUSCITATOR receive FDA 510(k) clearance?

MERLIN RESUSCITATOR received FDA 510(k) clearance on 2004-07-16, under 510(k) number K031395.

Who is the listed applicant for MERLIN RESUSCITATOR?

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

What is the FDA product code for MERLIN RESUSCITATOR?

The FDA product code for MERLIN RESUSCITATOR is BTM.

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Other records listing Merlin Medical Limited as applicant

K031397MERLIN E-MASK

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.