The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Electromedics D1079e.
Device ID | K873561 |
510k Number | K873561 |
Device Name: | ELECTROMEDICS D1079E |
Classification | Heat-exchanger, Cardiopulmonary Bypass |
Applicant | ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
Contact | Dennis Mcelwee |
Correspondent | Dennis Mcelwee ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
Product Code | DTR |
CFR Regulation Number | 870.4240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-02 |
Decision Date | 1987-11-05 |