FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAXI ASPIRATOR
K Number: K902184
·
Decision Feb 12, 1991
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
19
Review Days
274
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Basic Information
- Device Name
- MAXI ASPIRATOR
- K Number
- K902184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Industries America, Inc.
- Date Received
- May 14, 1990
- Decision Date
- February 12, 1991
- Product Code
- BTI
- 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 |
|---|---|---|---|
| BTI | Compressor, Air, Portable | FDA class 2 | Anesthesiology |
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