510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172892Substantially Equivalent

Neuro Assessment System NAS-1000

Headsense Medical, Inc., Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172892 is the FDA 510(k) clearance record for Neuro Assessment System NAS-1000, a class II device, cleared for Headsense Medical, Inc. on under FDA product code QBE (Cranial Sound Monitor). FDA's definition for product code QBE reads: "To non-invasively detect, monitor, record and display acoustic signals in the brain". FDA records list one 510(k) clearance for Headsense Medical, Inc. As of , FDA records show no recalls naming K172892.

Clearance record

Decision date
Received
(167 days to decision)
Product code
QBE Cranial Sound Monitor
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Applicant
Headsense Medical, Inc. 520 S. Main St., Akron OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBE

Trailing 12 months

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

FDA records show no clearances under product code QBE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QBE, 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