FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BREATHING FILTER
K Number: K931217
·
Decision Apr 23, 1993
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
2
Review Days
44
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Basic Information
- Device Name
- BREATHING FILTER
- K Number
- K931217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teknor Medical Products, Inc.
- Date Received
- March 10, 1993
- Decision Date
- April 23, 1993
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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Other Clearances by Teknor Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931216 | CONNECTORS AND AIRWAY EXTENSIONS | Apr 23, 1993 | Substantially Equivalent |