FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
K Number: K020932
·
Decision Jun 28, 2002
Classifications
1
FEI Numbers
187
Registration Numbers
188
Same Product Code
503
Applicant Total
14
Review Days
98
Basic Information
- Device Name
- DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
- K Number
- K020932
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SUNRISE MEDICAL
- Date Received
- March 22, 2002
- Decision Date
- June 28, 2002
- Product Code
- CAF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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