510(k) K051007
K051007 is an FDA 510(k) premarket notification submitted by Miti Corp. for the device "ACCU02 SYSTEM". The FDA issued a decision of Substantially Equivalent on June 16, 2005. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2005
- Date Received
- April 20, 2005
- 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