The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Ultrasound Video Bronchoscope, Model Eb-1970uk.
| Device ID | K081518 |
| 510k Number | K081518 |
| Device Name: | ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE RD. Montvale, NJ 07645 -1856 |
| Contact | Paul Silva |
| Correspondent | Paul Silva PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE RD. Montvale, NJ 07645 -1856 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-30 |
| Decision Date | 2008-09-05 |
| Summary: | summary |