The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Capno Module, 92517.
Device ID | K130112 |
510k Number | K130112 |
Device Name: | CAPNO MODULE, 92517 |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466 |
Contact | Thomas Kroenke |
Correspondent | Thomas Kroenke SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-16 |
Decision Date | 2013-03-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10841522113093 | K130112 | 000 |
10841522108839 | K130112 | 000 |