The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Lci-100 And Lci-200 Welch Allyn Illumination And Imaging System.
| Device ID | K940270 |
| 510k Number | K940270 |
| Device Name: | LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | WELCH ALLYN, INC. 4619 JORDAN RD. Skaneateles Falls, NY 13153 -0187 |
| Contact | David Klementowski |
| Correspondent | David Klementowski WELCH ALLYN, INC. 4619 JORDAN RD. Skaneateles Falls, NY 13153 -0187 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1994-04-20 |