CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105— 510(k) K090646
Substantially EquivalentChest M.I., Inc.
FDA 510(k) clearance K090646 for CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105, Substantially Equivalent on 2009-07-23. Applicant: Chest M.I., Inc.. Device class: 2.
Clearance details
- Applicant
- Chest M.I., 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
- Austin, TX, US
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