510(k) K922477
K922477 is an FDA 510(k) premarket notification submitted by Infrasonics Corp. for the device "MODEL 105 VENTILATOR, MODIFICATION". The FDA issued a decision of Substantially Equivalent on August 24, 1992. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Infrasonics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1992
- Date Received
- May 27, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type