510(k) K905000
K905000 is an FDA 510(k) premarket notification submitted by Corometrics Medical Systems, Inc. for the device "ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER". The FDA issued a decision of Substantially Equivalent on January 31, 1991. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Corometrics Medical Systems, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1991
- Date Received
- November 7, 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