TRAUMA CARE EVALUATION— 510(k) K843905

Substantially Equivalent

Quantitative

FDA 510(k) clearance K843905 for TRAUMA CARE EVALUATION, Substantially Equivalent on 1985-09-26. Applicant: Quantitative. Device class: 2.

Clearance details

Applicant: Quantitative
Product code: Code PLB
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1984-10-03
Decision date: 1985-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLB

K240756 — AITRICS-VC2024-07-23
K240558 — NAVOYCDS2024-07-22
K230386 — SpassageQ2023-06-15
K213423 — T3 Platform software2023-01-06
K183282 — Biovitals Analytics Engine2019-08-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.