The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Physiological Monitor, Models 101,301,201,202,303a.
Device ID | K854840 |
510k Number | K854840 |
Device Name: | PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A |
Classification | Electrocardiograph |
Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
Contact | Richard A Mentelos |
Correspondent | Richard A Mentelos IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-04 |
Decision Date | 1986-05-07 |