The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Rich-mar Delta 330 Hv.
Device ID | K844217 |
510k Number | K844217 |
Device Name: | RICH-MAR DELTA 330 HV |
Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
Applicant | RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 |
Contact | David Richards |
Correspondent | David Richards RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 |
Product Code | IMG |
CFR Regulation Number | 890.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-31 |
Decision Date | 1984-11-27 |