The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Patient Monitor Model 405p.
Device ID | K955546 |
510k Number | K955546 |
Device Name: | PATIENT MONITOR MODEL 405P |
Classification | Electrocardiograph |
Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
Contact | Dick Listro |
Correspondent | Dick Listro 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 | 1995-12-05 |
Decision Date | 1996-08-16 |
Summary: | summary |