The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Ls100 Halogen Examination Light, Model No: 44100.
| Device ID | K921493 |
| 510k Number | K921493 |
| Device Name: | LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100 |
| Classification | Device, Medical Examination, Ac Powered |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | John Watkins |
| Correspondent | John Watkins WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | KZF |
| CFR Regulation Number | 880.6320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-30 |
| Decision Date | 1992-11-03 |