510(k) K910462
K910462 is an FDA 510(k) premarket notification submitted by Imex Medical Systems, Inc. for the device "POCKET DOP 3". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code HEP (Monitor, Blood-Flow, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Imex Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1991
- Date Received
- February 4, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Blood-Flow, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type