The following data is part of a premarket notification filed by Orsense Ltd with the FDA for Nbm-200mp Pulse Oximetry Device.
| Device ID | K091564 |
| 510k Number | K091564 |
| Device Name: | NBM-200MP PULSE OXIMETRY DEVICE |
| Classification | Oximeter |
| Applicant | ORSENSE LTD 20 HATA'AS ST Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein ORSENSE LTD 20 HATA'AS ST Kfar Saba, IL 44425 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-28 |
| Decision Date | 2010-03-19 |
| Summary: | summary |