The following data is part of a premarket notification filed by Can-am Medical, Inc. with the FDA for C.p.r. Landmarc.
Device ID | K900415 |
510k Number | K900415 |
Device Name: | C.P.R. LANDMARC |
Classification | Aid, Cardiopulmonary Resuscitation |
Applicant | CAN-AM MEDICAL, INC. 21 ROSS STREET, DRYDEN Ontario P8n 1t8, CA |
Contact | Carla K Hanson |
Correspondent | Carla K Hanson CAN-AM MEDICAL, INC. 21 ROSS STREET, DRYDEN Ontario P8n 1t8, CA |
Product Code | LIX |
CFR Regulation Number | 870.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-30 |
Decision Date | 1990-06-12 |