510(k) K023014
K023014 is an FDA 510(k) premarket notification submitted by Pulmonox Medical, Inc. for the device "VIANOX DELIVERY SYSTEM, MODEL I". The FDA issued a decision of Substantially Equivalent on August 14, 2003. The device falls under product code MRP (Analyzer, Nitric Oxide), a Class II device regulated under 21 CFR 868.2380. Pulmonox Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2003
- Date Received
- September 10, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Nitric Oxide
- Device Class
- Class II
- Regulation Number
- 868.2380
- Review Panel
- AN
- Submission Type