510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182242Substantially Equivalent

VO200 – NeurOs Cerebral Oximetry System

Mespere Lifesciences Inc., Waterloo, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182242 is the FDA 510(k) clearance record for VO200 – NeurOs Cerebral Oximetry System, a class II device, cleared for Mespere Lifesciences, Inc. on under FDA product code QEM (Cerebral Oximeter). FDA's definition for product code QEM reads: "Oximeter to measure cerebral tissue saturation". FDA records list 3 510(k) clearances for Mespere Lifesciences, Inc., from to . As of , FDA records show no recalls naming K182242.

Clearance record

Decision date
Received
(128 days to decision)
Product code
QEM Cerebral Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Mespere Lifesciences, Inc. 180 Frobisher Dr. Suite 1c, Waterloo, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEM

Trailing 12 months

FDA records hold no clearances under product code QEM in the trailing twelve months.

FDA records show no clearances under product code QEM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QEM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260