The following data is part of a premarket notification filed by Pirdy, Inc. with the FDA for Pird-y.
Device ID | K842262 |
510k Number | K842262 |
Device Name: | PIRD-Y |
Classification | Stimulator, Muscle, Diagnostic |
Applicant | PIRDY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ISB |
CFR Regulation Number | 890.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-07 |
Decision Date | 1984-06-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PIRD-Y 73558006 1453622 Dead/Cancelled |
YLVISAKER, CARL J. 1985-09-13 |