510(k) K132903
K132903 is an FDA 510(k) premarket notification submitted by Dre Medical, Inc. for the device "DRE VENTURA". The FDA issued a decision of Substantially Equivalent on July 1, 2014. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2014
- Date Received
- September 16, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type