The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Monitor, Citadel Intravascular Po2.
Device ID | K760350 |
510k Number | K760350 |
Device Name: | MONITOR, CITADEL INTRAVASCULAR PO2 |
Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCE |
CFR Regulation Number | 868.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-02 |
Decision Date | 1976-10-29 |