510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K936108Substantially Equivalent

Masterscreen Body

Erich Jaeger GmbH & Co. KG, Wuerzburg, Germany, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K936108 is the FDA 510(k) clearance record for MASTERSCREEN BODY, a class II device, cleared for Erich Jaeger GmbH & Co. KG on under FDA product code JEH (Plethysmograph, Volume). FDA records list 4 510(k) clearances for Erich Jaeger GmbH & Co. KG, from to . As of , FDA records show no recalls naming K936108.

Clearance record

Decision date
Received
(403 days to decision)
Product code
JEH Plethysmograph, Volume
Regulation
21 CFR 868.1760
Device class
Class II
Review panel
Anesthesiology
Applicant
Erich Jaeger GmbH & Co. KG Postfach 5846, 8700 Wuerzburg, Wuerzburg, Germany, DE
510(k) summary
Statement
Third party review
No

Clearances, product code JEH

Trailing 12 months

FDA records hold no clearances under product code JEH in the trailing twelve months.

FDA records show no clearances under product code JEH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JEH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260