The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Front-line Doc.
| Device ID | K984215 |
| 510k Number | K984215 |
| Device Name: | WELCH ALLYN FRONT-LINE DOC |
| Classification | System, Image Processing, Radiological |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Colin Wolff |
| Correspondent | Colin Wolff WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-24 |
| Decision Date | 1999-02-11 |
| Summary: | summary |