The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Nellcor Puritan Bennett Uniprobe Adapter Cable, Up12a, Up12b, Up12c.
Device ID | K982728 |
510k Number | K982728 |
Device Name: | NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C |
Classification | Oximeter |
Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
Contact | Sheryll A Mathews |
Correspondent | Sheryll A Mathews NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-05 |
Decision Date | 1998-12-07 |
Summary: | summary |