The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Medley Sp02 Module, Model 8220.
| Device ID | K010966 |
| 510k Number | K010966 |
| Device Name: | MEDLEY SP02 MODULE, MODEL 8220 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-02 |
| Decision Date | 2001-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403822018 | K010966 | 000 |