The following data is part of a premarket notification filed by Spes Medica S.r.l. with the FDA for Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,.
| Device ID | K091410 |
| 510k Number | K091410 |
| Device Name: | DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | SPES MEDICA S.R.L. VIA EUROPA-ZONA INDUSTRIALE Battipaglia, IT 84091 |
| Contact | Alfredo Spadavecchia |
| Correspondent | Alfredo Spadavecchia SPES MEDICA S.R.L. VIA EUROPA-ZONA INDUSTRIALE Battipaglia, IT 84091 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-13 |
| Decision Date | 2009-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B006NVWGNA102 | K091410 | 000 |
| IDKMF512B5 | K091410 | 000 |
| B006IDKHRN61252 | K091410 | 000 |
| B006IDKKRF614B52 | K091410 | 000 |
| B006IDKMCF512B52 | K091410 | 000 |
| B006IDKSHEMM52 | K091410 | 000 |
| B006NPDC52 | K091410 | 000 |
| B006NPDCA52 | K091410 | 000 |
| B006NPFC52 | K091410 | 000 |
| B006NVGNA102 | K091410 | 000 |
| IDKATF714B5 | K091410 | 000 |