510(k) K844247
K844247 is an FDA 510(k) premarket notification submitted by Technicare Corp. for the device "ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS". The FDA issued a decision of Substantially Equivalent on January 23, 1985. The device falls under product code GXX (Block, Test, Ultrasonic Scanner Calibration), a Class I device regulated under 21 CFR 882.1925. Technicare Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1985
- Date Received
- November 1, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Test, Ultrasonic Scanner Calibration
- Device Class
- Class I
- Regulation Number
- 882.1925
- Review Panel
- NE
- Submission Type