The following data is part of a premarket notification filed by Kmi Kolster Methods, Inc. with the FDA for Xub External Ultrasound.
| Device ID | K010702 |
| 510k Number | K010702 |
| Device Name: | XUB EXTERNAL ULTRASOUND |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | KMI KOLSTER METHODS, INC. 1170 N. GILBERT ST. Anaheim, CA 92801 |
| Contact | Alwin H Kolster |
| Correspondent | Alwin H Kolster KMI KOLSTER METHODS, INC. 1170 N. GILBERT ST. Anaheim, CA 92801 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-08 |
| Decision Date | 2001-08-09 |