Sigma Medical, Inc.
Indianapolis, IN, US
Sigma Medical, Inc. appears in FDA device records in Indianapolis, IN. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Sigma Medical, Inc. in 1985.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 13 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K853065 | #6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAG | CAI | Substantially Equivalent | |
| K853344 | 4000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT | CAI | Substantially Equivalent | |
| K853343 | 3015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT W | CAI | Substantially Equivalent | |
| K853342 | 6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG | CAI | Substantially Equivalent | |
| K852314 | #6010 NON-CONDUCTIVE VENTILATOR CIRCUIT | CAI | Substantially Equivalent | |
| K852316 | #3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | Substantially Equivalent | |
| K852315 | #3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | Substantially Equivalent | |
| K852313 | #3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | Substantially Equivalent | |
| K852312 | #3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | Substantially Equivalent | |
| K852311 | #3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | Substantially Equivalent | |
| K851531 | 4013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAG | CAI | Substantially Equivalent | |
| K851530 | 4003 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREAT\GAS | CAI | Substantially Equivalent | |
| K851529 | 4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL | CAI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain