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 |