The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Vital Signs Monitor.
Device ID | K083821 |
510k Number | K083821 |
Device Name: | VITAL SIGNS MONITOR |
Classification | Oximeter |
Applicant | EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
Contact | William Stern |
Correspondent | William Stern EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-22 |
Decision Date | 2009-05-14 |
Summary: | summary |