The following data is part of a premarket notification filed by Eare Consulting Service with the FDA for Lite-blade.
| Device ID | K944428 |
| 510k Number | K944428 |
| Device Name: | LITE-BLADE |
| Classification | Laryngoscope, Rigid |
| Applicant | EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
| Contact | Emanuel A Rosen |
| Correspondent | Emanuel A Rosen EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-12 |
| Decision Date | 1994-11-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LITE-BLADE 74625192 not registered Dead/Abandoned |
TRUPHATEK INTERNATIONAL LIMITED 1995-01-24 |