The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Vital Signs Monitor.
| Device ID | K102835 |
| 510k Number | K102835 |
| 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 | 2010-09-29 |
| Decision Date | 2010-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871021968 | K102835 | 000 |
| 00815871021234 | K102835 | 000 |
| 00815871021241 | K102835 | 000 |
| 00815871021258 | K102835 | 000 |
| 00815871021265 | K102835 | 000 |
| 00815871021272 | K102835 | 000 |
| 00815871021289 | K102835 | 000 |
| 00815871021296 | K102835 | 000 |
| 00815871021302 | K102835 | 000 |
| 00815871021319 | K102835 | 000 |
| 00815871021326 | K102835 | 000 |
| 00815871021333 | K102835 | 000 |
| 00815871021227 | K102835 | 000 |