The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Cp100 & 200 12-lead Resting Electrocardiographs.
| Device ID | K072449 |
| 510k Number | K072449 |
| Device Name: | CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS |
| Classification | Electrocardiograph |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | John Sawyer |
| Correspondent | John Sawyer 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 | 2007-08-31 |
| Decision Date | 2007-11-29 |
| Summary: | summary |