The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Diagnostic Cardiology Suite 2.x.x With Spirometry Option.
| Device ID | K191013 |
| 510k Number | K191013 |
| Device Name: | Welch Allyn Diagnostic Cardiology Suite 2.X.X With Spirometry Option |
| Classification | Spirometer, Diagnostic |
| Applicant | Welch Allyn, Inc. 7865 North 86th St. Milwaukee, WI 53224 |
| Contact | Megan Pellenz |
| Correspondent | Megan Pellenz Welch Allyn, Inc. 7865 North 86th St. Milwaukee, WI 53224 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-17 |
| Decision Date | 2019-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094325393 | K191013 | 000 |
| 00732094324037 | K191013 | 000 |
| 00732094324051 | K191013 | 000 |
| 00732094315479 | K191013 | 000 |
| 00732094315493 | K191013 | 000 |
| 00732094315486 | K191013 | 000 |
| 00732094325652 | K191013 | 000 |
| 00817655022598 | K191013 | 000 |
| 00817655022604 | K191013 | 000 |
| 00817655022611 | K191013 | 000 |
| 00817655022628 | K191013 | 000 |
| 00732094324006 | K191013 | 000 |
| 00732094324013 | K191013 | 000 |
| 00732094324044 | K191013 | 000 |
| 00732094325379 | K191013 | 000 |
| 00732094325386 | K191013 | 000 |