The following data is part of a premarket notification filed by Machida America, Inc. with the FDA for Machida Flexible Nasopharyngo-laryngoscope Fns-1.
| Device ID | K844834 |
| 510k Number | K844834 |
| Device Name: | MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | MACHIDA AMERICA, INC. 40 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Ron Pell |
| Correspondent | Ron Pell 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 | 1984-12-12 |
| Decision Date | 1985-06-11 |