DISPOSABLE DIAPHRAGM DOMES

Transducer, Blood-pressure, Extravascular

MEDEX, INC.

The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Disposable Diaphragm Domes.

Pre-market Notification Details

• Device ID: K820355
• 510k Number: K820355
• Device Name: DISPOSABLE DIAPHRAGM DOMES
• Classification: Transducer, Blood-pressure, Extravascular
• Applicant: MEDEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DRS
• CFR Regulation Number: 870.2850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-02-08
• Decision Date: 1982-03-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50351688501170	K820355	000
50351688505116	K820355	000
50351688505734	K820355	000
50351688506670	K820355	000
50351688508469	K820355	000
50351688508926	K820355	000
50351688509008	K820355	000
50351688509053	K820355	000
50351688509282	K820355	000
50351688509299	K820355	000
50351688509305	K820355	000
50351688502948	K820355	000
50351688502931	K820355	000
50351688502924	K820355	000
50351688501989	K820355	000
50351688502009	K820355	000
50351688502818	K820355	000
50351688502825	K820355	000
50351688502832	K820355	000
50351688502849	K820355	000
50351688502870	K820355	000
50351688502887	K820355	000
50351688502894	K820355	000
50351688502917	K820355	000
50351688509381	K820355	000
50351688509404	K820355	000
50351688517836	K820355	000
50351688517850	K820355	000
50351688518888	K820355	000
50351688518895	K820355	000
50351688510738	K820355	000
50351688504713	K820355	000
50351688517881	K820355	000
50351688504690	K820355	000
50351688505062	K820355	000
50351688504669	K820355	000
50351688517775	K820355	000
50351688517768	K820355	000
50351688517720	K820355	000
50351688509466	K820355	000
50351688509503	K820355	000
50351688509527	K820355	000
50351688509565	K820355	000
50351688509572	K820355	000
50351688509596	K820355	000
50351688510349	K820355	000
50351688510684	K820355	000
50351688510783	K820355	000
50351688510790	K820355	000
35019517090417	K820355	000