Disposable Patient Cable

FDA 510(k) K910645 · Diag Corp.

Substantially Equivalent

510(k) numberK910645

Submission

Device name
Disposable Patient Cable
Applicant
Diag Corp.
Minnetonka, MN, US
Received
February 13, 1991
Decision date
May 7, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2900
Specialty
Cardiovascular

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Questions and answers

When was Disposable Patient Cable cleared by the FDA?

Disposable Patient Cable (K910645) received a 510(k) decision of Substantially Equivalent on May 7, 1991, 83 days after the submission was received.

What is the product code of K910645?

The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.