The following data is part of a premarket notification filed by Optus, Inc. with the FDA for Optus Bronchoscopes.
| Device ID | K945268 |
| 510k Number | K945268 |
| Device Name: | OPTUS BRONCHOSCOPES |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231 |
| Contact | Peter Duffy |
| Correspondent | Peter Duffy OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1995-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059082029740 | K945268 | 000 |
| 04059082029733 | K945268 | 000 |
| 04059082029726 | K945268 | 000 |
| 04059082029719 | K945268 | 000 |
| 04059082003986 | K945268 | 000 |
| 04059082003962 | K945268 | 000 |
| 04059082003955 | K945268 | 000 |
| 04059082003948 | K945268 | 000 |