The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Model 6000 Two Parameter Bedside Monitor.
Device ID | K091787 |
510k Number | K091787 |
Device Name: | MODEL 6000 TWO PARAMETER BEDSIDE MONITOR |
Classification | Oximeter |
Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
Contact | Jennifer Laine |
Correspondent | Jennifer Laine IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-17 |
Decision Date | 2009-10-09 |
Summary: | summary |