FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
AEROSOL ONE, NEBULIZER PUMP
K Number: K870428
·
Decision May 15, 1987
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
12
Review Days
101
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Basic Information
- Device Name
- AEROSOL ONE, NEBULIZER PUMP
- K Number
- K870428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ashai Co. , Ltd.
- Date Received
- February 3, 1987
- Decision Date
- May 15, 1987
- 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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Other Clearances by Ashai Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K852622 | AEROSOL ONE | Apr 24, 1986 | Substantially Equivalent |
| K852620 | SAFE.N.SURE | Oct 31, 1985 | Substantially Equivalent |
| K852627 | MAXI-NEB | Sep 26, 1985 | Substantially Equivalent |
| K852628 | NASAL ONE | Sep 18, 1985 | Substantially Equivalent |
| K852625 | OXY-TUBE | Sep 18, 1985 | Substantially Equivalent |
| K852629 | AERO-MASK TWO | Sep 18, 1985 | Substantially Equivalent |
| K852624 | OXY-TWO | Sep 18, 1985 | Substantially Equivalent |
| K852618 | OXY-DIAL | Sep 18, 1985 | Substantially Equivalent |
| K852626 | AERO-MASK ONE | Sep 18, 1985 | Substantially Equivalent |
| K852623 | OXY-ONE | Sep 18, 1985 | Substantially Equivalent |