The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Lx 150 Light Source.
| Device ID | K922095 |
| 510k Number | K922095 |
| Device Name: | LX 150 LIGHT SOURCE |
| Classification | Source, Carrier, Fiberoptic Light |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Lawrence E Marocco |
| Correspondent | Lawrence E Marocco WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-05 |
| Decision Date | 1992-07-17 |