The following data is part of a premarket notification filed by Optim, Inc. with the FDA for Entity Nasoview Led Nasopharyngoscope, Model 006105.
| Device ID | K080622 |
| 510k Number | K080622 |
| Device Name: | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | OPTIM, INC. 64 TECHNOLOGY PARK RD. Sturbridge, MA 01566 -1262 |
| Contact | Robert Krupa |
| Correspondent | Robert Krupa OPTIM, INC. 64 TECHNOLOGY PARK RD. Sturbridge, MA 01566 -1262 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-05 |
| Decision Date | 2008-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085119004132 | K080622 | 000 |
| 00858119004170 | K080622 | 000 |
| 00858119004163 | K080622 | 000 |
| 00858119004156 | K080622 | 000 |
| 00858119004149 | K080622 | 000 |
| 00858119004125 | K080622 | 000 |
| 00858119004002 | K080622 | 000 |
| 00858119004132 | K080622 | 000 |