Burke Neutech, Inc.
Largo, FL, US
Burke Neutech, Inc. appears in FDA device records in Largo, FL. FDA records list 7 510(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
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Burke Neutech, Inc. between 1993 and 1996. The busiest year on record is 1995, with 3. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 3 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K955326 | SPORTS CONTRAST THERAPY SYSTEM ST 7000 | ILO | Substantially Equivalent for Some Indications | |
| K952117 | EPILATOR | KCX | Substantially Equivalent | |
| K943497 | CONTRAST 7000 THERAPY SYSTEM | ILO | Substantially Equivalent | |
| K945803 | THERMAFLEX, MODEL SD 55 C.P.M.H. | JFA | Substantially Equivalent | |
| K942926 | NEURO-AIDE | GWY | Substantially Equivalent | |
| K940160 | TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM | ILO | Substantially Equivalent | |
| K926151 | LSI6000 THERMAL THERAPY SYSTEM | ILO | 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