Pressure Monitoring Lines

FDA 510(k) K802326 · Stanco Medical, Inc.

Substantially Equivalent

510(k) numberK802326

Submission

Device name
Pressure Monitoring Lines
Applicant
Stanco Medical, Inc.
Mchenry, IL, US
Received
September 23, 1980
Decision date
October 10, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DRI – Monitor, Line Isolation
Device class
Class I (low risk)
Regulation
21 CFR 870.2620
Specialty
Cardiovascular

Other 510(k)s with product code DRI

510(k)DeviceApplicantDecision
K902493Cardiocap II CG-2GS, 2G, 1GS, 1G, 2CG, CS MonitorDRI · Traditional Datex Division Instrumentarium Corp.07/06/1990SE
K902492Cardiocap II Monitors: CH, CH-2, Ch-S, CH-2SDRI · Traditional Datex Division Instrumentarium Corp.07/06/1990SE
K822316Heart Monitor Bracelet AlarmDRI · Traditional Hmba09/21/1982SE

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Questions and answers

When was Pressure Monitoring Lines cleared by the FDA?

Pressure Monitoring Lines (K802326) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 17 days after the submission was received.

What is the product code of K802326?

The FDA product code is DRI – Monitor, Line Isolation, a Class I (low risk) device regulated under 21 CFR 870.2620.