510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981378Substantially Equivalent

Datex-Engstrom Light Monitor Models F-Lm1, F-Lmp1

Datex-Engstrom, Inc., Tewksburt MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981378 is the FDA 510(k) clearance record for DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1, a class II device, cleared for Datex-Engstrom, Inc. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 10 510(k) clearances for Datex-Engstrom, Inc., from to . As of , FDA records show no recalls naming K981378.

Clearance record

Decision date
Received
(201 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Datex-Engstrom, Inc. 3 Highwood Dr., Tewksburt MA
510(k) summary
Statement
Third party review
No

Clearances, product code DRT

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