The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Swartz Doppler Flow Probe And Monitor System.
| Device ID | K964001 |
| 510k Number | K964001 |
| Device Name: | SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Fearnot, Ph.d., E.e. |
| Correspondent | Neal E Fearnot, Ph.d., E.e. MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1998-04-17 |
| Summary: | summary |