S12X WITH ESAX OPTION— 510(k) K082629
Substantially EquivalentChatten Associates, Inc.
FDA 510(k) clearance K082629 for S12X WITH ESAX OPTION, Substantially Equivalent on 2009-07-01. Applicant: Chatten Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- Chatten Associates, Inc.
- Product code
- Code GYC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Conshohocken, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.