CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER— 510(k) K972509
Substantially EquivalentNuccardiac Software, Inc.
FDA 510(k) clearance K972509 for CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER, Substantially Equivalent on 1997-09-08. Applicant: Nuccardiac Software, Inc.. Device class: 2.
Clearance details
- Applicant
- Nuccardiac Software, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yorba Linda, CA, US
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