510(k) K030517
K030517 is an FDA 510(k) premarket notification submitted by Viasys Healthcare, Inc. for the device "BALL RECORDING ELECTRODE/STIMULATION PROBE". The FDA issued a decision of Substantially Equivalent on August 1, 2003. The device falls under product code GZK (Electrode, Nasopharyngeal), a Class II device regulated under 21 CFR 882.1340. Viasys Healthcare, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2003
- Date Received
- February 19, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Nasopharyngeal
- Device Class
- Class II
- Regulation Number
- 882.1340
- Review Panel
- NE
- Submission Type