Micro Direct, Inc.
Lewiston, ME, US
MICRO DIRECT, INC. appears in FDA device records in Lewiston, ME. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Micro Direct, Inc. between 1994 and 2004. The busiest year on record is 1997, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1996 | 2 |
| 1997 | 3 |
| 2003 | 2 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K033688 | MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY | NRH | Substantially Equivalent | |
| K031102 | MICROLAB SPIROMETER | BZG | Substantially Equivalent | |
| K030586 | MICROPEAK | BZH | Substantially Equivalent | |
| K973314 | SPIROSAFE FILTER | CAH | Substantially Equivalent | |
| K965042 | MICRODL DIARYCARD SPIROMETER | BZG | Substantially Equivalent | |
| K963376 | MICRO H2 | NRH | Substantially Equivalent | |
| K963035 | MICRO SPIROMETER | BZG | Substantially Equivalent | |
| K950197 | MICROCO | CCJ | Substantially Equivalent | |
| K940375 | MICRO MPM | CAP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1223858 | 1000305581 | MICRO DIRECT, INC. | 803 WEBSTER ST, LEWISTON, ME 04240 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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