The following data is part of a premarket notification filed by Kada Research, Inc. with the FDA for Kadance 2000.
| Device ID | K012492 |
| 510k Number | K012492 |
| Device Name: | KADANCE 2000 |
| Classification | Dynamometer, Ac-powered |
| Applicant | KADA RESEARCH, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Contact | Harvey Knauss |
| Correspondent | Harvey Knauss KADA RESEARCH, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-03 |
| Decision Date | 2001-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B824SR3053S1 | K012492 | 000 |
| B824SR3053M1 | K012492 | 000 |