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FDA 510(k)

POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A

K-Number: K042727 · 2005-03-18

ApplicantForemount Ent. Co., Ltd.
Decision Date2005-03-18
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A is the device name listed in this FDA 510(k) record. The listed applicant is Foremount Ent. Co., Ltd.. It received FDA 510(k) clearance on 2005-03-18 under 510(k) number K042727. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A?

POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A is a medical device that received FDA 510(k) clearance on 2005-03-18. The listed applicant is Foremount Ent. Co., Ltd.. The 510(k) number is K042727.

When did POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A receive FDA 510(k) clearance?

POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A received FDA 510(k) clearance on 2005-03-18, under 510(k) number K042727.

Who is the listed applicant for POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A?

The FDA 510(k) record lists Foremount Ent. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A?

The FDA product code for POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A is CBP.

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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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