FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULMO-MIST COMPRESSOR MODEL # 4323
K Number: K020797
·
Decision May 3, 2002
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
73
Applicant Total
11
Review Days
52
Basic Information
- Device Name
- PULMO-MIST COMPRESSOR MODEL # 4323
- K Number
- K020797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NIDEK MEDICAL PRODUCTS, INC.
- Date Received
- March 12, 2002
- Decision Date
- May 3, 2002
- Product Code
- BTI
- 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 |
|---|---|---|---|
| BTI | Compressor, Air, Portable | FDA class 2 | Anesthesiology |
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