The following data is part of a premarket notification filed by Metracor Technologies, Inc. with the FDA for Roda (real Time Oxygen Dynamics Analysis) Monitoring System.
Device ID | K011238 |
510k Number | K011238 |
Device Name: | RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM |
Classification | Pump, Infusion, Analytical Sampling |
Applicant | METRACOR TECHNOLOGIES, INC. 11425 SORRENTO VALLEY RD. San Diego, CA 92121 |
Contact | George F Mchugh |
Correspondent | George F Mchugh METRACOR TECHNOLOGIES, INC. 11425 SORRENTO VALLEY RD. San Diego, CA 92121 |
Product Code | LZF |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-23 |
Decision Date | 2002-01-08 |