510(k) K092687
K092687 is an FDA 510(k) premarket notification submitted by A Plus Medical for the device "VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER". The FDA issued a decision of Substantially Equivalent on November 23, 2009. The device falls under product code NHK (Resuscitator, Manual, Non Self-Inflating), a Class II device regulated under 21 CFR 868.5905. A Plus Medical has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2009
- Date Received
- September 1, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resuscitator, Manual, Non Self-Inflating
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type
A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.