510(k) K010292
K010292 is an FDA 510(k) premarket notification submitted by Axiom Worldwide, Inc. for the device "DRX 2000". The FDA issued a decision of Substantially Equivalent on May 1, 2001. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Axiom Worldwide, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2001
- Date Received
- January 31, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type