The following data is part of a premarket notification filed by Mega Electronics Ltd. with the FDA for Mega Me 3000 Professional Muscle Tester.
| Device ID | K963202 |
| 510k Number | K963202 |
| Device Name: | MEGA ME 3000 PROFESSIONAL MUSCLE TESTER |
| Classification | Device, Biofeedback |
| Applicant | MEGA ELECTRONICS LTD. 1660 RIVERTON POINT Eagan, MN 55122 |
| Contact | Gregory J Mathison |
| Correspondent | Gregory J Mathison MEGA ELECTRONICS LTD. 1660 RIVERTON POINT Eagan, MN 55122 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1997-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035220243 | K963202 | 000 |
| 06430035220236 | K963202 | 000 |
| 06430035220212 | K963202 | 000 |
| 06430035220205 | K963202 | 000 |