FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTHMA MONITOR MODEL, AM1
K Number: K090486
·
Decision May 6, 2009
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
2
Review Days
70
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Basic Information
- Device Name
- ASTHMA MONITOR MODEL, AM1
- K Number
- K090486
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardinal Health Germany 234 GmbH
- Date Received
- February 25, 2009
- Decision Date
- May 6, 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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Other Clearances by Cardinal Health Germany 234 GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K082539 | MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT | Dec 2, 2008 | Substantially Equivalent |