The following data is part of a premarket notification filed by Medcomp (medical Components, Inc.) with the FDA for Celerity Ecg Cable Accessory Pack.
| Device ID | K171931 |
| 510k Number | K171931 |
| Device Name: | Celerity ECG Cable Accessory Pack |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Medcomp (Medical Components, Inc.) 1499 Delp Dr. Harleysville, PA 19438 |
| Contact | Colton Muraira |
| Correspondent | Colton Muraira Medcomp (Medical Components, Inc.) 1499 Delp Dr. Harleysville, PA 19438 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-28 |
| Decision Date | 2017-10-26 |
| Summary: | summary |