510(k) K905236
K905236 is an FDA 510(k) premarket notification submitted by Percussionaire Corp. for the device "IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES". The FDA issued a decision of Substantially Equivalent on April 18, 1991. The device falls under product code NHJ (Device, Positive Pressure Breathing, Intermittent), a Class II device regulated under 21 CFR 868.5905. Percussionaire Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1991
- Date Received
- November 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Positive Pressure Breathing, Intermittent
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type