The following data is part of a premarket notification filed by Mectronic Medicale S.r.l. with the FDA for Doctor Tecar.
Device ID | K183693 |
510k Number | K183693 |
Device Name: | Doctor Tecar |
Classification | Massager, Vacuum, Radio Frequency Induced Heat |
Applicant | Mectronic Medicale S.r.l. Via Orio Al Serio, 15 Grassobbio, IT 24050 |
Contact | Gloria Aloisini |
Correspondent | Gloria Aloisini Mectronic Medicale S.r.l. Via Orio Al Serio, 15 Grassobbio, IT 24050 |
Product Code | PBX |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-31 |
Decision Date | 2019-02-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08051499970864 | K183693 | 000 |
08051499970161 | K183693 | 000 |