The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Score Software.
Device ID | K961450 |
510k Number | K961450 |
Device Name: | SCORE SOFTWARE |
Classification | Oximeter |
Applicant | NELLCOR PURITAN BENNETT, INC. 10200 VALLEY VIEW RD. Eden Prairie, MN 55344 |
Contact | Chris Hadland |
Correspondent | Chris Hadland NELLCOR PURITAN BENNETT, INC. 10200 VALLEY VIEW RD. Eden Prairie, MN 55344 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-15 |
Decision Date | 1996-08-01 |
Summary: | summary |