510(k) K070416

NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP by Neoforce Group, Inc. — Product Code BYE

K070416 is an FDA 510(k) premarket notification submitted by Neoforce Group, Inc. for the device "NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP". The FDA issued a decision of Substantially Equivalent on May 29, 2007. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Neoforce Group, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2007
Date Received
February 12, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type