PERIFLUX 6000— 510(k) K131253
Substantially EquivalentPerimed AB
FDA 510(k) clearance K131253 for PERIFLUX 6000, Substantially Equivalent on 2013-10-22. Applicant: Perimed AB. Device class: 2.
Clearance details
- Applicant
- Perimed AB
- 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
- Abbreviated
- Location
- Jarfalla, SE
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
- K110474 — PHILIPS INTELLIVUE TCG10
- K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
- K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
More clearances from Perimed AB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.