The following data is part of a premarket notification filed by Truphatek International, Ltd. with the FDA for Tru-mr Laryngoscope Set.
| Device ID | K062523 |
| 510k Number | K062523 |
| Device Name: | TRU-MR LARYNGOSCOPE SET |
| Classification | Laryngoscope, Rigid |
| Applicant | TRUPHATEK INTERNATIONAL, LTD. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden TRUPHATEK INTERNATIONAL, LTD. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2006-11-17 |
| Summary: | summary |