FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
K Number: K091428
·
Decision Jan 27, 2010
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
3
Review Days
258
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Basic Information
- Device Name
- EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
- K Number
- K091428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ndd Medizitechnik AG
- Date Received
- May 14, 2009
- Decision Date
- January 27, 2010
- Product Code
- BTY
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
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