The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Bf Type Um40.
| Device ID | K021204 |
| 510k Number | K021204 |
| Device Name: | OLYMPUS BF TYPE UM40 |
| Classification | Ultrasound Bronchoscope |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | PSV |
| Subsequent Product Code | ITX |
| Subsequent Product Code | ODG |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-04-16 |
| Decision Date | 2002-05-01 |
| Summary: | summary |