The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Model 90419 Pulse Oximeter Module.
| Device ID | K864279 |
| 510k Number | K864279 |
| Device Name: | SPACELABS MODEL 90419 PULSE OXIMETER MODULE |
| Classification | Oximeter |
| Applicant | SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Allen Hans |
| Correspondent | Allen Hans SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-30 |
| Decision Date | 1987-03-11 |