The following data is part of a premarket notification filed by Mercury Medical with the FDA for Direct View 2001 Fiberlight.
| Device ID | K945901 |
| 510k Number | K945901 |
| Device Name: | DIRECT VIEW 2001 FIBERLIGHT |
| Classification | Laryngoscope, Rigid |
| Applicant | MERCURY MEDICAL 11300-A 49TH ST. NORTH Clearwater, FL 34622 -4800 |
| Contact | Kathy L Hann |
| Correspondent | Kathy L Hann MERCURY MEDICAL 11300-A 49TH ST. NORTH Clearwater, FL 34622 -4800 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-02 |
| Decision Date | 1994-12-27 |