The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Rich-mar Us-ii Ultrasound.
| Device ID | K950564 |
| 510k Number | K950564 |
| Device Name: | RICH-MAR US-II ULTRASOUND |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 -0879 |
| Contact | David Richards |
| Correspondent | David Richards RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 -0879 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-08 |
| Decision Date | 1995-05-15 |