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 |