SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
FDA premarket approval P880062/S002 · decided 1997-02-13
Approval details
- PMA number
- P880062
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
- Generic name
- Applicator, hyperthermia, deep heating, ultrasound
- Applicant
- Labthermics Technologies, Inc.
- Date received
- 1996-12-16
- Decision date
- 1997-02-13
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LNB
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Champaign, IL
- Statement
- APPROVAL FOR CHANGES TO THE COMPUTER SYSTEM AND REVISIONS TO THE OPERATOR'S MANUAL FOR THE SONOTHERM 1000.
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