The following data is part of a premarket notification filed by Consolidated Medical Equipment, Inc. with the FDA for Prn Ecg Electrode.
| Device ID | K850130 |
| 510k Number | K850130 |
| Device Name: | PRN ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | CONSOLIDATED MEDICAL EQUIPMENT, INC. 310 BROAD ST. Utica, NY 13501 |
| Contact | William W Abrahem |
| Correspondent | William W Abrahem CONSOLIDATED MEDICAL EQUIPMENT, INC. 310 BROAD ST. Utica, NY 13501 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-04-09 |