FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100
K Number: K960593
·
Decision May 10, 1996
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100
- K Number
- K960593
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aradigm Corp.
- Date Received
- February 12, 1996
- Decision Date
- May 10, 1996
- Product Code
- CCQ
- 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 |
|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | FDA class 1 | Anesthesiology |
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