Applicator, Hyperthermia, Deep Heating, Ultrasound

Product Code: LNB

Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as LNB

5434Applicator, Hyperthermia, Deep Heating, Ultrasound

Total Product Life Cycle (TPLC) Devices

5434Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Consensus Standards

Applicator, Hyperthermia, Deep Heating, Ultrasound [32412]21 CFR Unclassified 🔎
Applicator, Hyperthermia, Deep Heating, Ultrasound [32415]21 CFR Unclassified 🔎

Pre-market Approvals for LNB

P880062SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEMLABTHERMICS TECHNOLOGIES, INC.

Maude Adverse Events

BSD SIGMA 60 APPLICATORBSD MEDICAL CORP2002-03-29

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