AUTIMO 2.5-D AND AUTIMO 3-D— 510(k) K972016
Substantially EquivalentC.L. Mcintosh & Assoc., Inc.
FDA 510(k) clearance K972016 for AUTIMO 2.5-D AND AUTIMO 3-D, Substantially Equivalent on 1997-12-04. Applicant: C.L. Mcintosh & Assoc., Inc.. Device class: 2.
Clearance details
- Applicant
- C.L. Mcintosh & Assoc., Inc.
- Product code
- Code IXI
- Device class
- Class 2
- Regulation
- 21 CFR 892.5710
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code IXI
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