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510(k) K042727

POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A by Foremount Ent. Co., Ltd. — Product Code CBP

K042727 is an FDA 510(k) premarket notification submitted by Foremount Ent. Co., Ltd. for the device "POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A". The FDA issued a decision of Substantially Equivalent on March 18, 2005. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2005
Date Received
October 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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FDA data resources