The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Capnometer W/new Airway Adapter 47210a.
Device ID | K831447 |
510k Number | K831447 |
Device Name: | CAPNOMETER W/NEW AIRWAY ADAPTER 47210A |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | HEWLETT-PACKARD CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-05 |
Decision Date | 1983-11-21 |