FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BREATHING FILTER
K Number: K931842
·
Decision May 19, 1993
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
17
Review Days
36
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Basic Information
- Device Name
- BREATHING FILTER
- K Number
- K931842
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mag, Inc.
- Date Received
- April 13, 1993
- Decision Date
- May 19, 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 Mag, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942127 | M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS | Jun 22, 1994 | Substantially Equivalent |
| K942124 | GAS SAMPLING LINES AND CONNECTORS CIRCUITS | Jun 22, 1994 | Substantially Equivalent |
| K942129 | M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | Jun 22, 1994 | Substantially Equivalent |
| K942134 | M.A.G. INC. BREALTHING BAGS | Jun 22, 1994 | Substantially Equivalent |
| K942125 | VOLUME VENTILATOR | Jun 22, 1994 | Substantially Equivalent |
| K942133 | M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS | Jun 22, 1994 | Substantially Equivalent |
| K942131 | M.A.G. INC. GUEDEL AIRWAYS | Jun 22, 1994 | Substantially Equivalent |
| K942135 | M.A.G. INC. COAXIAL CIRCUITS | Jun 22, 1994 | Substantially Equivalent |
| K942126 | M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT | Jun 22, 1994 | Substantially Equivalent |
| K942132 | M.A.G. INC. HYPERINFLATION SYSTEM | Jun 22, 1994 | Substantially Equivalent |