510(k) K853737
- Device
- VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
- Applicant
- CAPINTEC, INC.
- 510(k) number
- K853737
- Product code
- IYY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-13
- Date received
- 1985-09-06
- Regulation
- 892.1410
- Classification name
- Synchronizer, Electrocardiograph, Nuclear
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOEL ORLINSKY
- Address
- 540 Alpha Dr. Pittsburgh PA US 15238 15238
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IYY #
Legacy Summary#
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FDA Review#
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