AIRGENT, MODEL AG7000010— 510(k) K082138
Substantially EquivalentPerfaction, Inc.
FDA 510(k) clearance K082138 for AIRGENT, MODEL AG7000010, Substantially Equivalent on 2009-01-23. Applicant: Perfaction, Inc.. Device class: 2.
Clearance details
- Applicant
- Perfaction, Inc.
- Product code
- Code KZE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5430
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.