The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Mr7000 With Time Manager Software (tms).
| Device ID | K934111 |
| 510k Number | K934111 |
| Device Name: | MR7000 WITH TIME MANAGER SOFTWARE (TMS) |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Contact | Dale Thanig |
| Correspondent | Dale Thanig DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-03 |
| Decision Date | 1994-11-02 |