510(k) K900505
K900505 is an FDA 510(k) premarket notification submitted by Medison Co., Ltd. for the device "SONOACE 88 PORTABLE ULTRASOUND SCANNER". The FDA issued a decision of Substantially Equivalent on August 10, 1990. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Medison Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1990
- Date Received
- February 2, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Imager, Ultrasonic Obstetric-Gynecologic
- Device Class
- Class II
- Regulation Number
- 884.2225
- Review Panel
- OB
- Submission Type