Patient Cable

FDA 510(k) K932704 · Sentry Medical Products, Inc.

Substantially Equivalent

510(k) numberK932704

Submission

Device name
Patient Cable
Applicant
Sentry Medical Products, Inc.
Irvine, CA, US
Received
June 3, 1993
Decision date
December 27, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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K934000Sentry Aqueous Gel ECG ElectrodesDRX · Traditional 08/30/1994SE
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K881670Accutemp PlusFMT · Traditional 11/22/1988SE
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Questions and answers

When was Patient Cable cleared by the FDA?

Patient Cable (K932704) received a 510(k) decision of Substantially Equivalent on December 27, 1993, 207 days after the submission was received.

What is the product code of K932704?

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.