510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K944833Substantially Equivalent

Digitrace Sleep Computer, Sleeppac, Home Sleep System

New England Medical Monitoring Co., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944833 is the FDA 510(k) clearance record for DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM, a class II device, cleared for New England Medical Monitoring Co. 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 one 510(k) clearance for New England Medical Monitoring Co. As of , FDA records show no recalls naming K944833.

Clearance record

Decision date
Received
(216 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 Monitoring Co. 286 Congress St., Boston MA
510(k) summary
Summary
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