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 |