E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.— 510(k) K900333
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K900333 for E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT., Substantially Equivalent on 1990-04-16. Applicant: Radiometer America, Inc.. Device class: 2.
Clearance details
- Applicant
- Radiometer America, Inc.
- Product code
- Code LKD
- Device class
- Class 2
- Regulation
- 21 CFR 868.2480
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
Recent devices under product code LKD
view all- K232516 — Sentec Digital Monitoring System (SDMS) tCOM+
- K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
- K131253 — PERIFLUX 6000
- K110474 — PHILIPS INTELLIVUE TCG10
- K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
More clearances from Radiometer America, Inc.
view all- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
- K991417 — ABL 735 ANALYZER
- K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
- K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.