510(k) K830325
K830325 is an FDA 510(k) premarket notification submitted by Bertone & Assoc. for the device "TIGER PULSE". The FDA issued a decision of Substantially Equivalent on March 1, 1983. The device falls under product code GZK (Electrode, Nasopharyngeal), a Class II device regulated under 21 CFR 882.1340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1983
- Date Received
- February 1, 1983
- Clearance Type
- Traditional
- 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