The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Bt-795/p Automated Autotrans.
Device ID | K860306 |
510k Number | K860306 |
Device Name: | BT-795/P AUTOMATED AUTOTRANS |
Classification | Apparatus, Autotransfusion |
Applicant | ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
Contact | Gary D Reeder |
Correspondent | Gary D Reeder ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
Product Code | CAC |
CFR Regulation Number | 868.5830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-28 |
Decision Date | 1986-03-06 |