Reynolds Medical, Ltd.
Hasbrouck, NJ, US
Reynolds Medical , Ltd. appears in FDA device records in Hasbrouck, NJ. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Reynolds Medical, Ltd. between 1982 and 2003. The busiest year on record is 2001, with 3. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1987 | 1 |
| 1989 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 3 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K024283 | CARDIODIRECT, MODELS 12M, 12I, 12S | DPS | Substantially Equivalent | |
| K013367 | CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K011345 | CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM | DXH | Substantially Equivalent | |
| K011837 | LIFECARD CF 7 DAY | MWJ | Substantially Equivalent | |
| K001025 | LIFECARD CF COMPACT RECORDER | DSH | Substantially Equivalent | |
| K991211 | EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM | DXH | Substantially Equivalent | |
| K972649 | CARDIOCALL CARDIAC EVENT RECORDER | DXH | Substantially Equivalent | |
| K951902 | PATHFINDER 700 HOLTER ANALYZER | DQK | Substantially Equivalent | |
| K943278 | TRACKER 2/TRACKER 3 HOLTER RECORDER | DSH | Substantially Equivalent | |
| K884126 | E-RAM | DSH | Substantially Equivalent | |
| K871344 | PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR | DSI | Substantially Equivalent | |
| K821516 | TRACKER-2 CHANNEL ECG TAPE RECORDER | DSH | 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