The following data is part of a premarket notification filed by Cp Medical with the FDA for Disposable Temporary Pacing Cable,models Cpw-bv-5,cpw-lg-5,cpw-sm-5,cpw-era300-5,cpw-qloc-5.
| Device ID | K022075 |
| 510k Number | K022075 |
| Device Name: | DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
| Contact | Mary Ann Greenawalt |
| Correspondent | Mary Ann Greenawalt CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-26 |
| Decision Date | 2002-09-19 |
| Summary: | summary |