510(k) K964208
K964208 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "MD-1A GALVANIC UNIT". The FDA issued a decision of Substantially Equivalent on April 30, 1997. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. R. A. Fischer Co. Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 1997
- Date Received
- October 4, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Iontophoresis, Other Uses
- Device Class
- Class II
- Regulation Number
- 890.5525
- Review Panel
- PM
- Submission Type