510(k) K910441
K910441 is an FDA 510(k) premarket notification submitted by Advance Medical Device, Inc. for the device "FLOSCOPE MICRODOP". The FDA issued a decision of Substantially Equivalent on March 21, 1991. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Advance Medical Device, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1991
- Date Received
- January 31, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Blood-Flow, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2120
- Review Panel
- CV
- Submission Type