510(k) K820533
K820533 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "B4182-1". The FDA issued a decision of Substantially Equivalent on April 8, 1982. The device falls under product code GIE (Fibrometer), a Class II device regulated under 21 CFR 864.5400. American Scientific Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1982
- Date Received
- March 2, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fibrometer
- Device Class
- Class II
- Regulation Number
- 864.5400
- Review Panel
- HE
- Submission Type