Vest(Ambulatory Ventricular Evaluating System)

FDA 510(k) K853737 · Capintec, Inc.

Substantially Equivalent

510(k) numberK853737

Submission

Device name
Vest(Ambulatory Ventricular Evaluating System)
Applicant
Capintec, Inc.
Pittsburgh, PA, US
Received
September 6, 1985
Decision date
February 13, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYY – Synchronizer, Electrocardiograph, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1410
Specialty
Radiology

Other 510(k)s with product code IYY

510(k)DeviceApplicantDecision
K790213Generator, R-WaveIYY · Traditional Amr Co.03/22/1979SE
K780510Nuclear StethoscopeIYY · Traditional Bios, Inc.04/18/1978SE

More from Bios, Inc.

510(k)DeviceDecision
K192199CRC PC Smart Chamber K1KPT · Special 09/12/2019SE
K162394CRC-77tHRKPT · Traditional 03/08/2017SE
K141413CRC PC with Smart ChamberKPT · Special 06/27/2014SE
K101452Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TWKPT · Special 08/09/2010SE
K071396CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsKPT · Special 06/28/2007SE
K052595CRC 15ULTRAJAQ · Traditional 11/08/2005SE
K0301752 BasicIYE · Traditional 04/17/2003SE
K020150CRC-15BTKPT · Traditional 08/02/2002SE
K982448CardiolightDSH · Traditional 06/11/1999SE
K980402Capintec Model 292 ElectrometerIYE · Traditional 04/24/1998SE

Questions and answers

When was Vest(Ambulatory Ventricular Evaluating System) cleared by the FDA?

Vest(Ambulatory Ventricular Evaluating System) (K853737) received a 510(k) decision of Substantially Equivalent on February 13, 1986, 160 days after the submission was received.

What is the product code of K853737?

The FDA product code is IYY – Synchronizer, Electrocardiograph, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1410.