The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Medley Spo2 Module, Model 8210 & Spo2 Sensors & Cable.
| Device ID | K022677 |
| 510k Number | K022677 |
| Device Name: | MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE |
| Classification | Oximeter |
| Applicant | ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Contact | Renee L Fluet |
| Correspondent | Renee L Fluet ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-12 |
| Decision Date | 2002-09-11 |
| Summary: | summary |