FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
TECHNOFIL
K Number: K953748
·
Decision Jan 25, 1996
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
2
Review Days
167
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Basic Information
- Device Name
- TECHNOFIL
- K Number
- K953748
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Technimeca Medic, Inc.
- Date Received
- August 11, 1995
- Decision Date
- January 25, 1996
- Product Code
- CAD
- 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | FDA class 2 | Anesthesiology |
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Other Clearances by Technimeca Medic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954801 | TECHFIL | Jan 25, 1996 | Substantially Equivalent |