FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
K Number: K090646
·
Decision Jul 23, 2009
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
2
Review Days
134
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Basic Information
- Device Name
- CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
- K Number
- K090646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chest M.I., Inc.
- Date Received
- March 11, 2009
- Decision Date
- July 23, 2009
- Product Code
- BZG
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K080921 | SPIRO-MASTER PC-10 SPIROMETRY SYSTEM | Jan 21, 2009 | Substantially Equivalent |