The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Disposable Sp02 Sensor.
| Device ID | K981655 |
| 510k Number | K981655 |
| Device Name: | SPACELABS MEDICAL DISPOSABLE SP02 SENSOR |
| Classification | Oximeter |
| Applicant | SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Nancy Gertlar |
| Correspondent | Nancy Gertlar SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-11 |
| Decision Date | 1999-12-03 |
| Summary: | summary |