The following data is part of a premarket notification filed by Orsense Ltd with the FDA for Nbm-200mp.
| Device ID | K124041 |
| 510k Number | K124041 |
| Device Name: | NBM-200MP |
| Classification | Oximeter |
| Applicant | ORSENSE LTD 901 NEW YORK AVE, N.W. Washington, DC 20001 |
| Contact | Mark A Heller |
| Correspondent | Mark A Heller ORSENSE LTD 901 NEW YORK AVE, N.W. Washington, DC 20001 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-10-17 |
| Summary: | summary |