Synectics-Dantec
Chicago, IL, US
Synectics-Dantec appears in FDA device records in Chicago, IL. FDA records list 19 510(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
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Synectics-Dantec between 1985 and 1997. The busiest year on record is 1991, with 3. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 3 |
| 1993 | 2 |
| 1994 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K961346 | PH ANALYSIS MODULE | FFT | Substantially Equivalent | |
| K925405 | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. | FFT | Substantially Equivalent | |
| K924875 | MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS | BZQ | Substantially Equivalent - Subject to Tracking Reg. | |
| K914793 | MONOCRYSTANT PH/LES CATHETER, MODIFICATION | KLA | Substantially Equivalent | |
| K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | FAP | Substantially Equivalent | |
| K913817 | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | FFT | Substantially Equivalent | |
| K914624 | PH METER, MODIFICATION | FFT | Substantially Equivalent | |
| K914219 | AIRWAY THERMISTOR | BZG | Substantially Equivalent | |
| K913387 | DIGITRAPPER MARK III | FFT | Substantially Equivalent | |
| K904625 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM | BZG | Substantially Equivalent | |
| K905520 | MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION | BZQ | Substantially Equivalent | |
| K900494 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM | FAP | Substantially Equivalent | |
| K902366 | MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT | FFT | Substantially Equivalent | |
| K880581 | AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. | FFX | Substantially Equivalent | |
| K872712 | PC POLYGRAF | KLA | Substantially Equivalent | |
| K871282 | SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE | FFT | Substantially Equivalent | |
| K862929 | SYNECTICS MOTILITY SYSTEM | FFT | Substantially Equivalent | |
| K853648 | SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO | FFT | Substantially Equivalent | |
| K850361 | SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E | FFT | 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