The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Co2 Monitoring Line With And Without In-line Filter.
| Device ID | K143150 |
| 510k Number | K143150 |
| Device Name: | CO2 Monitoring Line With And Without In-line Filter |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, TW Taiwan |
| Contact | Winnie Chung |
| Correspondent | Paul Dryden BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, TW Taiwan |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-02-05 |
| Summary: | summary |