The following data is part of a premarket notification filed by Mega Electronics Ltd. with the FDA for Femiscan Clinic System, Model Fs-ictra And Femiscan Personal System, Model Fs-hmtr.
| Device ID | K993411 |
| 510k Number | K993411 |
| Device Name: | FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR |
| Classification | Perineometer |
| Applicant | MEGA ELECTRONICS LTD. 200 NORTH MAIN ST. SOUTH BUILDING, SUITE 6 East Longmeadow, MA 01028 |
| Contact | David Mahoney |
| Correspondent | David Mahoney MEGA ELECTRONICS LTD. 200 NORTH MAIN ST. SOUTH BUILDING, SUITE 6 East Longmeadow, MA 01028 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-12 |
| Decision Date | 2000-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035220021 | K993411 | 000 |
| 06430035220014 | K993411 | 000 |