SPIRODOC— 510(k) K103530
Substantially EquivalentMedical International Research USA, Inc.
FDA 510(k) clearance K103530 for SPIRODOC, Substantially Equivalent on 2011-11-21. Applicant: Medical International Research USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical International Research USA, Inc.
- Product code
- Code BZG
- Device class
- Class 2
- Regulation
- 21 CFR 868.1840
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code BZG
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