FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
#3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K Number: K852315
·
Decision Jul 15, 1985
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
13
Review Days
47
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Basic Information
- Device Name
- #3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
- K Number
- K852315
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sigma Medical, Inc.
- Date Received
- May 29, 1985
- Decision Date
- July 15, 1985
- Product Code
- CAI
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
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Other Clearances by Sigma Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853065 | #6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAG | Sep 3, 1985 | Substantially Equivalent |
| K853343 | 3015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT W | Aug 29, 1985 | Substantially Equivalent |
| K853342 | 6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG | Aug 29, 1985 | Substantially Equivalent |
| K853344 | 4000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT | Aug 29, 1985 | Substantially Equivalent |
| K852314 | #6010 NON-CONDUCTIVE VENTILATOR CIRCUIT | Aug 13, 1985 | Substantially Equivalent |
| K852316 | #3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | Jul 15, 1985 | Substantially Equivalent |
| K852311 | #3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | Jul 15, 1985 | Substantially Equivalent |
| K852312 | #3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | Jul 15, 1985 | Substantially Equivalent |
| K852313 | #3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | Jul 15, 1985 | Substantially Equivalent |
| K851531 | 4013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAG | Apr 25, 1985 | Substantially Equivalent |