SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
FDA premarket approval P880062 · decided 1989-09-29
Approval details
- PMA number
- P880062
- Trade name
- SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
- Generic name
- Applicator, hyperthermia, deep heating, ultrasound
- Applicant
- Labthermics Technologies, Inc.
- Date received
- 1988-08-08
- Decision date
- 1989-09-29
- Days to decision
- 417 days
- Decision code
- APPR
- Product code
- LNB
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Champaign, IL
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.