PREMIER AP— 510(k) K982221
Substantially EquivalentAmerican Imex
FDA 510(k) clearance K982221 for PREMIER AP, Substantially Equivalent on 1998-09-22. Applicant: American Imex. Device class: 2.
Clearance details
- Applicant
- American Imex
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code GZJ
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