FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
TRANSPARENT ANESTHESIA FILTER
K Number: K944189
·
Decision Oct 28, 1994
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
2
Review Days
72
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Basic Information
- Device Name
- TRANSPARENT ANESTHESIA FILTER
- K Number
- K944189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Anetec, Inc.
- Date Received
- August 17, 1994
- Decision Date
- October 28, 1994
- 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 Anetec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K891479 | DISPOSABLE THERMOPLASTIC ANESTH BREATHING CIRCUITS | May 5, 1989 | Substantially Equivalent |