The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Model 90489 Pulse Oximeter Module.
Device ID | K901209 |
510k Number | K901209 |
Device Name: | MODEL 90489 PULSE OXIMETER MODULE |
Classification | Oximeter |
Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Contact | W Gifford |
Correspondent | W Gifford SPACELABS, INC. 15220 N.E. 40TH ST. 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 | 1990-03-14 |
Decision Date | 1990-04-30 |