510(k) K093260
K093260 is an FDA 510(k) premarket notification submitted by International Biomedical, Ltd. for the device "AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 2009. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. International Biomedical, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2009
- Date Received
- October 19, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Nitric Oxide Delivery
- Device Class
- Class II
- Regulation Number
- 868.5165
- Review Panel
- AN
- Submission Type