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 |