510(k) K052335
K052335 is an FDA 510(k) premarket notification submitted by Accutron, Inc. for the device "ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA". The FDA issued a decision of Substantially Equivalent on November 23, 2005. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Accutron, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2005
- Date Received
- August 26, 2005
- 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