The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Cp150 Electrocardiograph.
Device ID | K131573 |
510k Number | K131573 |
Device Name: | CP150 ELECTROCARDIOGRAPH |
Classification | Electrocardiograph |
Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
Contact | Kevin Crossen |
Correspondent | Kevin Crossen 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-30 |
Decision Date | 2013-07-03 |
Summary: | summary |