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 |