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 |