510(k) K092364
K092364 is an FDA 510(k) premarket notification submitted by Cyberonics, Inc. for the device "MODEL 220 PATIENT MAGNET". The FDA issued a decision of Substantially Equivalent on November 3, 2009. The device falls under product code DTG (Magnet, Test, Pacemaker), a Class I device regulated under 21 CFR 870.3690.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2009
- Date Received
- August 5, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnet, Test, Pacemaker
- Device Class
- Class I
- Regulation Number
- 870.3690
- Review Panel
- CV
- Submission Type