510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K004007Substantially Equivalent

Dr180+oxy

North East Monitoring, Inc., Sudbury MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K004007 is the FDA 510(k) clearance record for DR180+OXY, a class II device, cleared for North East Monitoring, Inc. on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 10 510(k) clearances for North East Monitoring, Inc., from to . As of , FDA records show no recalls naming K004007.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
North East Monitoring, Inc. 730 Boston Post Rd., Sudbury MA
510(k) summary
Summary
Third party review
No

Clearances, product code DSH

Trailing 12 months
3 clearances under product code DSH 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 DSH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260