510(k) K090958
K090958 is an FDA 510(k) premarket notification submitted by Ino Therapeutics, LLC for the device "INOMAX DS (DELIVERY SYSTEM)". The FDA issued a decision of Substantially Equivalent on June 18, 2009. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Ino Therapeutics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2009
- Date Received
- April 6, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type