The following data is part of a premarket notification filed by Totemite Medical Electronics with the FDA for Easi Lead System Cable Assembly.
| Device ID | K872781 |
| 510k Number | K872781 |
| Device Name: | EASI LEAD SYSTEM CABLE ASSEMBLY |
| Classification | Adaptor, Lead Switching, Electrocardiograph |
| Applicant | TOTEMITE MEDICAL ELECTRONICS BOX F110-232 264 "H" STREET Blaine, WA 98230 |
| Contact | Dower, M.d. |
| Correspondent | Dower, M.d. TOTEMITE MEDICAL ELECTRONICS BOX F110-232 264 "H" STREET Blaine, WA 98230 |
| Product Code | DRW |
| CFR Regulation Number | 870.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-14 |
| Decision Date | 1987-12-29 |