The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Roche Sensor Adaptor.
Device ID | K791559 |
510k Number | K791559 |
Device Name: | ROCHE SENSOR ADAPTOR |
Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
Applicant | ROCHE MEDICAL ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLK |
CFR Regulation Number | 868.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-17 |
Decision Date | 1979-11-21 |