Curbell Patient Monitoring Cables

FDA 510(k) K081762 · Curbell Electronics, Inc.

Substantially Equivalent

510(k) numberK081762

Submission

Device name
Curbell Patient Monitoring Cables
Applicant
Curbell Electronics, Inc.
Greenwood Village, CO, US
Received
June 20, 2008
Decision date
August 27, 2008
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary 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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More from Baylis Medical Technologies, Inc.

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Questions and answers

When was Curbell Patient Monitoring Cables cleared by the FDA?

Curbell Patient Monitoring Cables (K081762) received a 510(k) decision of Substantially Equivalent on August 27, 2008, 68 days after the submission was received.

What is the product code of K081762?

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.