Sechrist Industries, Inc.
Cable Assy. Rdmtr Interior
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Sechrist Industries, Inc., United States |
|---|---|
| FDA product code | LKD |
| Device type | Monitor, Carbon-Dioxide, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2480 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K905225 |
| Record published | 2023-08-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22191-1 | In distribution | |
| 22193 | In distribution | |
| 22192-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TCM4x Cable | Radiometer Medical APS | 5 |
| TC pO2/pCO2 Membraning kit For TC electrode | Radiometer Medical APS | 2 |
| TC electrode | Radiometer Medical APS | 2 |
| Fixation kit N20 | Radiometer Medical APS | 1 |
| TC pO2/pCO2 electrode | Radiometer Medical APS | 1 |
| Calibration Gas | Radiometer Medical APS | 1 |
| TCM4XX ETX Serial adapter, cable for TCM4XX ETX | Radiometer Medical APS | 1 |
| TCM Tosca module | Radiometer Medical APS | 1 |
| Extension cable For TCM3 electrodes, 3m | Radiometer Medical APS | 1 |
| tc Sensor 84 | Radiometer Medical APS | 1 |
| Philips IntelliVue TcG10 | Philips Medizin Systeme Böblingen GmbH | 1 |
| TCM4 combi module, TCpO2/O2 combi module | Radiometer Medical APS | 1 |
Showing 12 of 23. All products under Monitor, Carbon-Dioxide, Cutaneous
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840037 | 1986-11-19 | MODEL 515 NEONATAL MONIOTR | GE Medical Systems Information Technologies, Inc. |
| P850087 | 1986-11-14 | LITTON TRANSCUTANEOUS CO2 SYSTEM | Litton Datamedix |
| P820019 | 1986-03-03 | LIFESPAN(TM) 100 TCPCO2 MONITOR | Biochem International, Inc. |
| P810022 | 1985-11-21 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. |
| P830008 | 1984-10-29 | CUTANIOUS GAS MONITOR | Sensor Medics Corp. |
| P820025 | 1984-04-18 | TCPCO2 MONITORING SYSTEM | Narco Scientific |
| P800043 | 1984-03-01 | RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO | Radiometer America, Inc. |
| P810037 | 1982-12-22 | KONTRON CUTANEOUS PCO2 MONITOR | Kontron Cardiovascular |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.