The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Npb-290 Pulse Oximeter (npb-290).
Device ID | K972837 |
510k Number | K972837 |
Device Name: | NPB-290 PULSE OXIMETER (NPB-290) |
Classification | Oximeter |
Applicant | NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
Contact | Roger D Brown |
Correspondent | Roger D Brown NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-31 |
Decision Date | 1997-10-21 |
Summary: | summary |