The following data is part of a premarket notification filed by Rms Div. with the FDA for Sunmed's Greenline Fiber Optic Laryngoscope.
| Device ID | K954438 |
| 510k Number | K954438 |
| Device Name: | SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE |
| Classification | Laryngoscope, Rigid |
| Applicant | RMS DIV. 1247 FLORDIA AVE. Palm Harbor, FL 34683 |
| Contact | George D Cranton |
| Correspondent | George D Cranton RMS DIV. 1247 FLORDIA AVE. Palm Harbor, FL 34683 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-25 |
| Decision Date | 1995-12-29 |