The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Cardiac Outpur/saturated Venous Oxygen Module.
Device ID | K893867 |
510k Number | K893867 |
Device Name: | CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE |
Classification | Oximeter |
Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Contact | Raymond Gifford |
Correspondent | Raymond 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 | 1989-05-26 |
Decision Date | 1989-09-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10841522106293 | K893867 | 000 |