GATED MIBI 3-D EJECTION FRACTION PROCESSING— 510(k) K961597
Substantially EquivalentTrionix Research Laboratory, Inc.
FDA 510(k) clearance K961597 for GATED MIBI 3-D EJECTION FRACTION PROCESSING, Substantially Equivalent on 1996-09-04. Applicant: Trionix Research Laboratory, Inc.. Device class: 2.
Clearance details
- Applicant
- Trionix Research Laboratory, 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
- Twinsburg, OH, US
Recent devices under product code KPS
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