The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Oxinet N-7500 Pulse Oximetry Network.
Device ID | K884142 |
510k Number | K884142 |
Device Name: | OXINET N-7500 PULSE OXIMETRY NETWORK |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
Contact | Michael C Maloney |
Correspondent | Michael C Maloney NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-30 |
Decision Date | 1988-12-16 |