The following data is part of a premarket notification filed by Minrad, Inc. with the FDA for Mr Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001.
| Device ID | K062231 |
| 510k Number | K062231 |
| Device Name: | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 |
| Classification | Laryngoscope, Rigid |
| Applicant | MINRAD, INC. 847 MAIN ST. Buffalo, NY 14203 |
| Contact | John Mcneirney |
| Correspondent | John Mcneirney MINRAD, INC. 847 MAIN ST. Buffalo, NY 14203 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-02 |
| Decision Date | 2006-08-31 |
| Summary: | summary |