ASTRASONIC SPIROMETER, MODEL 29-8000— 510(k) K092813
Substantially EquivalentSdi Diagnostics, Inc.
FDA 510(k) clearance K092813 for ASTRASONIC SPIROMETER, MODEL 29-8000, Substantially Equivalent on 2010-07-16. Applicant: Sdi Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sdi Diagnostics, 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
- Easton, MA, US
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