Owandy Inc.
Garden City, NY, US
OWANDY INC. appears in FDA device records in Garden City, NY. FDA records list 6 510(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 6 510(k) clearances for Owandy Inc. between 2006 and 2014. The busiest year on record is 2006, with 1. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133271 | OPTEO, VIDEOGRAPH HD | MUH | Substantially Equivalent | |
| K130443 | I-MAX TOUCH 3D | OAS | Substantially Equivalent | |
| K093105 | VISTEO | EHD | Substantially Equivalent | |
| K083057 | I-MAX TOUCH | MUH | Substantially Equivalent | |
| K070505 | KRYSTAL-X WIFI | MUH | Substantially Equivalent | |
| K062403 | IMAX CEPH DIGITAL X-RAY SENSOR | MUH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011632261 | 3011632261 | OWANDY INC. | 585 STEWART AVE, Garden City, NY 11530 US | 2026 | No device listings on this registration |
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