The following data is part of a premarket notification filed by Machida America, Inc. with the FDA for Machida Semi-rigid Bronchoscope Fbs-6r-50.
| Device ID | K854581 |
| 510k Number | K854581 |
| Device Name: | MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | MACHIDA AMERICA, INC. 40 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | James Bradley |
| Correspondent | James Bradley MACHIDA AMERICA, INC. 40 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-15 |
| Decision Date | 1986-02-28 |