The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn #48100 Task Lite W/accessories As List.
Device ID | K852949 |
510k Number | K852949 |
Device Name: | WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST |
Classification | Device, Medical Examination, Ac Powered |
Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
Contact | Robert W Becker |
Correspondent | Robert W Becker 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 | 1985-07-11 |
Decision Date | 1985-09-04 |