The following data is part of a premarket notification filed by Phasein Ab with the FDA for Veo Multigas Monitor For Pocket Pc.
Device ID | K081601 |
510k Number | K081601 |
Device Name: | VEO MULTIGAS MONITOR FOR POCKET PC |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | PHASEIN AB 4213 WINNEQUAH DR. Madison, WI 53716 |
Contact | David Weissburg |
Correspondent | David Weissburg PHASEIN AB 4213 WINNEQUAH DR. Madison, WI 53716 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-06 |
Decision Date | 2008-09-04 |
Summary: | summary |