510(k) K023245
K023245 is an FDA 510(k) premarket notification submitted by Paradigm Medical Industries, Inc. for the device "BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01". The FDA issued a decision of Substantially Equivalent on October 21, 2002. The device falls under product code NJJ (Tonometer, Analyzer, Ocular Blood Flow), a Class II device regulated under 21 CFR 886.1930. Paradigm Medical Industries, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2002
- Date Received
- September 30, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Analyzer, Ocular Blood Flow
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type
Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent. Description of why current product c lassificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does. However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume.