FDA 510(k)
FDA class 1
Substantially Equivalent
🇸🇪 Sweden
AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H
K Number: K945359
·
Decision Feb 21, 1995
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
5
Review Days
111
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Basic Information
- Device Name
- AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H
- K Number
- K945359
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Artema Medical AB
- Date Received
- November 2, 1994
- Decision Date
- February 21, 1995
- Product Code
- BYD
- 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | FDA class 1 | Anesthesiology |
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