510(k) K895365

MD-2 IONTOPHORESIS UNIT by R. A. Fischer Co. Corp. — Product Code EGJ

K895365 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "MD-2 IONTOPHORESIS UNIT". The FDA issued a decision of Substantially Equivalent with Drug on Jun 26, 1990. 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 12 other 510(k) clearances on record.

Clearance details

Decision
SESD (Substantially Equivalent with Drug)
Decision Date
Jun 26, 1990
Date Received
Aug 28, 1989
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
510(k)

Source: FDA 510(k) database entry for K895365. Report a data issue: hello@regdatalab.com.