FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUSTIN INHALATOR
K Number: K823246
·
Decision Dec 16, 1982
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
61
Applicant Total
2
Review Days
45
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Basic Information
- Device Name
- AUSTIN INHALATOR
- K Number
- K823246
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ems Industries, Inc.
- Date Received
- November 1, 1982
- Decision Date
- December 16, 1982
- Product Code
- BYX
- 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 |
|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | FDA class 1 | Anesthesiology |
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Other Clearances by Ems Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823247 | U-WAY QUICKOLLAR | Nov 16, 1982 | Substantially Equivalent |