510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081861Substantially Equivalent

Holter Lx Analysis

North East Monitoring, Inc., Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081861 is the FDA 510(k) clearance record for HOLTER LX ANALYSIS, a class II device, cleared for North East Monitoring, Inc. on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list 10 510(k) clearances for North East Monitoring, Inc., from to . As of , FDA records show no recalls naming K081861.

Clearance record

Decision date
Received
(156 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
North East Monitoring, Inc. 80 Shelton Technology Center, Shelton CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNR

Trailing 12 months
6 clearances under product code MNR in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MNR, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20260
September 20261
October 20260