The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Ecg Electrodes, Pediatric-foam Tape.
| Device ID | K791002 |
| 510k Number | K791002 |
| Device Name: | ECG ELECTRODES, PEDIATRIC-FOAM TAPE |
| Classification | Electrode, Electrocardiograph |
| Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-29 |
| Decision Date | 1979-06-01 |