510(k) K030878
K030878 is an FDA 510(k) premarket notification submitted by Metron Medical Australia, Pty, Ltd. for the device "ACCOUSONIC, MODEL AS-270". The FDA issued a decision of Substantially Equivalent on March 28, 2003. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Metron Medical Australia, Pty, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2003
- Date Received
- March 20, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5300
- Review Panel
- PM
- Submission Type