The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Infant Ecg Electrode #60-1029.
| Device ID | K810102 |
| 510k Number | K810102 |
| Device Name: | INFANT ECG ELECTRODE #60-1029 |
| Classification | Electrode, Electrocardiograph |
| Applicant | ASPEN LABORATORIES, INC. 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 | 1981-01-16 |
| Decision Date | 1981-01-29 |