The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Adagio Retracting Ecg Lead Wires.
| Device ID | K093657 |
| 510k Number | K093657 |
| Device Name: | ADAGIO RETRACTING ECG LEAD WIRES |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | ACIST MEDICAL SYSTEMS, INC. 7905 FULLER ROAD Eden Prairie, MN 55344 |
| Contact | Al Saalabi |
| Correspondent | Al Saalabi ACIST MEDICAL SYSTEMS, INC. 7905 FULLER ROAD Eden Prairie, MN 55344 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-25 |
| Decision Date | 2010-01-15 |
| Summary: | summary |