Lumex, Inc.
Bay Shore, NY, US
Lumex, Inc. appears in FDA device records in Bay Shore, NY. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Lumex, Inc. between 1990 and 1997. The busiest year on record is 1995, with 3. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K963674 | LUMEX AIR | FNM | Substantially Equivalent | |
| K962123 | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM | FNM | Substantially Equivalent | |
| K953675 | ALTADYNE | FNM | Substantially Equivalent | |
| K945175 | MECHANICAL WHEELCHAIR 890.3850 | IOR | Substantially Equivalent | |
| K945257 | 577ES (ERGOSENSE) | INO | Substantially Equivalent | |
| K944574 | LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) | IOR | Substantially Equivalent | |
| K923977 | AKROTECH 4000 | IOQ | Substantially Equivalent | |
| K895740 | SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART | FPO | 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