The following data is part of a premarket notification filed by Markcare Medical Systems, Inc. with the FDA for Intrascan(r) Mini-pacs.
| Device ID | K934311 |
| 510k Number | K934311 |
| Device Name: | INTRASCAN(R) MINI-PACS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MARKCARE MEDICAL SYSTEMS, INC. 87 ROUTE 17 NORTH Maywood, NJ 07607 |
| Contact | John A Reilling |
| Correspondent | John A Reilling MARKCARE MEDICAL SYSTEMS, INC. 87 ROUTE 17 NORTH Maywood, NJ 07607 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-01 |
| Decision Date | 1993-12-13 |