FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
PULMOTRACK 2020 SYSTEM
K Number: K102229
·
Decision Mar 4, 2011
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
4
Review Days
207
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Basic Information
- Device Name
- PULMOTRACK 2020 SYSTEM
- K Number
- K102229
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1900
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karmelsonix
- Date Received
- August 9, 2010
- Decision Date
- March 4, 2011
- Product Code
- BZM
- 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 |
|---|---|---|---|
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | FDA class 2 | Anesthesiology |
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