The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Cardioperfect Workstation Software (cpws) V 1.62.
| Device ID | K082478 |
| 510k Number | K082478 |
| Device Name: | WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 |
| Classification | Spirometer, Diagnostic |
| 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 | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-28 |
| Decision Date | 2009-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094185515 | K082478 | 000 |
| 00732094336214 | K082478 | 000 |
| 00732094336207 | K082478 | 000 |
| 00732094336191 | K082478 | 000 |
| 00732094336139 | K082478 | 000 |
| 00732094336122 | K082478 | 000 |
| 00732094336115 | K082478 | 000 |
| 00732094336092 | K082478 | 000 |
| 00732094336085 | K082478 | 000 |
| 00732094070767 | K082478 | 000 |
| 00732094336689 | K082478 | 000 |
| 00732094336696 | K082478 | 000 |
| 00732094088649 | K082478 | 000 |
| 00732094070286 | K082478 | 000 |
| 00732094057942 | K082478 | 000 |
| 00732094043488 | K082478 | 000 |
| 00732094041002 | K082478 | 000 |
| 00732094040852 | K082478 | 000 |
| 00732094040838 | K082478 | 000 |
| 00732094208634 | K082478 | 000 |
| 00732094336177 | K082478 | 000 |
| 00732094058307 | K082478 | 000 |