Optus, Inc.
Denver, CO, US
Optus, Inc. appears in FDA device records in Denver, CO. FDA records list 10 510(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
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Optus, Inc. between 1994 and 1996. The busiest year on record is 1995, with 6. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1995 | 6 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K945264 | OPTUS OTOSCOPES | ERA | Substantially Equivalent | |
| K953913 | OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES | HRX | Substantially Equivalent | |
| K945268 | OPTUS BRONCHOSCOPES | EOQ | Substantially Equivalent | |
| K945265 | OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES | HIH | Substantially Equivalent | |
| K945262 | OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES | FAJ | Substantially Equivalent | |
| K945267 | OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES | HRX | Substantially Equivalent | |
| K945266 | OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES | GCJ | Substantially Equivalent | |
| K944656 | OPTUS SINUSCOPES AND ACCESSORIES | EOB | Substantially Equivalent | |
| K945263 | OPTUS THORACOSCOPES | GCJ | Substantially Equivalent | |
| K945269 | OPTUS LARYNGOSCOPES | CCW | 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