The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Sidestream Pump Plug-in Module Of Component Monitoring System.
Device ID | K943389 |
510k Number | K943389 |
Device Name: | SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | HEWLETT-PACKARD CO. 175 WYMAN ST. P.O. BOX 9030 Waltham, MS 02254 |
Contact | Ray Stelting |
Correspondent | Ray Stelting HEWLETT-PACKARD CO. 175 WYMAN ST. P.O. BOX 9030 Waltham, MS 02254 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-14 |
Decision Date | 1995-03-17 |