The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for 12-lead Resting Electrocardiograph, Models Cp100 & Cp200.
| Device ID | K050074 |
| 510k Number | K050074 |
| Device Name: | 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 |
| Classification | Electrocardiograph |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Christopher Klaczykn |
| Correspondent | Christopher Klaczykn WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-12 |
| Decision Date | 2005-03-22 |
| Summary: | summary |