510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910771Substantially Equivalent

Digitrace(tm) Home Monit Comp/elb(tm) EEG Lunch Bx

New England Medical Instruments, Inc., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910771 is the FDA 510(k) clearance record for DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX, a class II device, cleared for New England Medical Instruments, Inc. on under FDA product code OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph). FDA's definition for product code OMB reads: "Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output...". FDA records list 3 510(k) clearances for New England Medical Instruments, Inc., from to . As of , FDA records show no recalls naming K910771.

Clearance record

Decision date
Received
(299 days to decision)
Product code
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
New England Medical Instruments, Inc. 10 Pheasant Ln., Lexington MA
Third party review
No

Clearances, product code OMB

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