The following data is part of a premarket notification filed by Medatron, Inc. with the FDA for Medatron Cuvette Disc.
| Device ID | K873656 |
| 510k Number | K873656 |
| Device Name: | MEDATRON CUVETTE DISC |
| Classification | Cuvette, Thermostated |
| Applicant | MEDATRON, INC. C/O PROFESSIONAL BILLING CO. 250 BISHOPS WAY Brookfield, WI 53005 |
| Contact | Kim Kaufmann |
| Correspondent | Kim Kaufmann MEDATRON, INC. C/O PROFESSIONAL BILLING CO. 250 BISHOPS WAY Brookfield, WI 53005 |
| Product Code | JRI |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-10 |
| Decision Date | 1987-12-14 |