The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Vital Signs Monitor Model M3b.
| Device ID | K101539 |
| 510k Number | K101539 |
| Device Name: | VITAL SIGNS MONITOR MODEL M3B |
| Classification | Oximeter |
| Applicant | EDAN INSTRUMENTS, INC. NANHAI ROAD 1019#, SHEKOU, Shenzhen, Guangdong, CN 51067 |
| Contact | Randy Jiang |
| Correspondent | Randy Jiang EDAN INSTRUMENTS, INC. NANHAI ROAD 1019#, SHEKOU, Shenzhen, Guangdong, CN 51067 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2010-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871021364 | K101539 | 000 |
| 00815871021357 | K101539 | 000 |
| 00815871021340 | K101539 | 000 |