510(k) K060751
K060751 is an FDA 510(k) premarket notification submitted by Inovo, Inc. for the device "INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR". The FDA issued a decision of Substantially Equivalent on July 18, 2006. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Inovo, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2006
- Date Received
- March 21, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conserver, Oxygen
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type