510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923043Substantially Equivalent

Spectral EEG Monitor Model A1000

Aspect Medical Systems, Inc., Framingham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923043 is the FDA 510(k) clearance record for SPECTRAL EEG MONITOR MODEL A1000, a class II device, cleared for Aspect Medical Systems, Inc. on under FDA product code OLT (Non-Normalizing Quantitative Electroencephalograph Software). FDA's definition for product code OLT reads: "Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user". FDA records list 25 510(k) clearances for Aspect Medical Systems, Inc., from to . As of , FDA records show no recalls naming K923043.

Clearance record

Decision date
Received
(162 days to decision)
Product code
OLT Non-Normalizing Quantitative Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Aspect Medical Systems, Inc. 770 Cochituate Rd., Framingham MA
510(k) summary
Statement
Third party review
No

Clearances, product code OLT

Trailing 12 months
4 clearances under product code OLT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20261
October 20260