The following data is part of a premarket notification filed by Bedfont Scientific Ltd with the FDA for Toxco.
Device ID | K173238 |
510k Number | K173238 |
Device Name: | ToxCO |
Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
Applicant | Bedfont Scientific Ltd Station Road, Harrietsham Maidstone, GB Me17 1ja |
Contact | Louise Bateman |
Correspondent | Louise Bateman Bedfont Scientific Ltd Station Road, Harrietsham Maidstone, GB Me17 1ja |
Product Code | CCJ |
CFR Regulation Number | 868.1430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-05 |
Decision Date | 2019-04-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060246860030 | K173238 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TOXCO 79198790 5343260 Live/Registered |
Bedfont Scientific Limited 2016-07-11 |