510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980380Substantially Equivalent

Neurotrend Multiparameter Sensor, C7004s, to Operate with Paratrend 7+ Multiparameter Sensor, Mpm7001s, and Satellite Ms

Diametrics Medical, Inc., High Wycombe, Buckinghamshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980380 is the FDA 510(k) clearance record for NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS, a class II device, cleared for Diametrics Medical, Ltd. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 11 510(k) clearances for Diametrics Medical, Ltd., from to . As of , FDA records show no recalls naming K980380.

Clearance record

Decision date
Received
(527 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Diametrics Medical, Ltd. Short St., High Wycombe, Buckinghamshire, GB
510(k) summary
Summary
Third party review
No

Clearances, product code GWM

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