The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs' Model 90514, Multigas Analyzer.
Device ID | K896427 |
510k Number | K896427 |
Device Name: | SPACELABS' MODEL 90514, MULTIGAS ANALYZER |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
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 | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-08 |
Decision Date | 1990-01-24 |