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 |