The following data is part of a premarket notification filed by Welch Allyn with the FDA for Cp150 Electrocardiograph With Spirometry Option.
| Device ID | K141582 |
| 510k Number | K141582 |
| Device Name: | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION |
| Classification | Electrocardiograph |
| Applicant | WELCH ALLYN 4341 STATE STREET ROAD Skaneateles Falls, NY 13153 |
| Contact | Kevin Crossen |
| Correspondent | Kevin Crossen WELCH ALLYN 4341 STATE STREET ROAD Skaneateles Falls, NY 13153 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2014-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094192254 | K141582 | 000 |
| 00732094088601 | K141582 | 000 |
| 00732094088595 | K141582 | 000 |
| 00732094070415 | K141582 | 000 |
| 00732094070194 | K141582 | 000 |
| 00732094070132 | K141582 | 000 |
| 00732094069891 | K141582 | 000 |
| 00732094322415 | K141582 | 000 |
| 00732094214093 | K141582 | 000 |
| 00732094088625 | K141582 | 000 |
| 00732094088816 | K141582 | 000 |
| 00732094179637 | K141582 | 000 |
| 00732094177640 | K141582 | 000 |
| 00732094177633 | K141582 | 000 |
| 00732094142488 | K141582 | 000 |
| 00732094089325 | K141582 | 000 |
| 00732094089134 | K141582 | 000 |
| 00732094089110 | K141582 | 000 |
| 00732094088847 | K141582 | 000 |
| 00732094214086 | K141582 | 000 |