The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Cardioperfect Workstation Version 1.5.0 Software.
| Device ID | K052158 |
| 510k Number | K052158 |
| Device Name: | WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE |
| Classification | Spirometer, Diagnostic |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-09 |
| Decision Date | 2005-09-08 |
| Summary: | summary |