TCM400— 510(k) K001866
Substantially EquivalentRadiometer Medical A/S
FDA 510(k) clearance K001866 for TCM400, Substantially Equivalent on 2000-12-07. Applicant: Radiometer Medical A/S. Device class: 2.
Clearance details
- Applicant
- Radiometer Medical A/S
- Product code
- Code LPP
- Device class
- Class 2
- Regulation
- 21 CFR 868.2500
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bronshoj, DK
Recent devices under product code LPP
view allMore clearances from Radiometer Medical A/S
view allRecalls naming K001866
K-number listed on FDA's recall record- Z-1755-2020 — TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.
- Z-1930-2013 — TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001866.
Data sourced from openFDA. This site is unofficial and independent of the FDA.