The following data is part of a premarket notification filed by Cardiac Evaluation Center, Inc. with the FDA for Retrospective Ii-elite Ecg Memory Loop Recorder.
| Device ID | K954163 |
| 510k Number | K954163 |
| Device Name: | RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARDIAC EVALUATION CENTER, INC. 2063 SOUTH 116TH ST. P.O. BOX 27327 Milwaukee, WI 53227 |
| Contact | Jim Mcguire |
| Correspondent | Jim Mcguire CARDIAC EVALUATION CENTER, INC. 2063 SOUTH 116TH ST. P.O. BOX 27327 Milwaukee, WI 53227 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1996-07-11 |
| Summary: | summary |