510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974101Substantially Equivalent

Datex-Engstrom Network

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

K974101 is the FDA 510(k) clearance record for DATEX-ENGSTROM NETWORK, a class II device, cleared for Datex-Engstrom, Inc. on under FDA product code MSX (System, Network And Communication, Physiological Monitors). FDA records list 10 510(k) clearances for Datex-Engstrom, Inc., from to . As of , FDA records show no recalls naming K974101.

Clearance record

Decision date
Received
(99 days to decision)
Product code
MSX System, Network And Communication, Physiological Monitors
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Datex-Engstrom, Inc. 2 Highwood Dr., Tewksbury MA
510(k) summary
Statement
Third party review
No

Clearances, product code MSX

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