The following data is part of a premarket notification filed by Fiab Spa with the FDA for Pg471w , Pg471/50w, Pg474w, Pg477w, Pg479/32w, Pg479/50w, Pg479/75w Fiab Disposable Electrodes With Cable For Electro-st.
| Device ID | K091163 |
| 510k Number | K091163 |
| Device Name: | PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST |
| Classification | Electrode, Cutaneous |
| Applicant | FIAB SPA VIA COSTOLI, 4 VICCHIO Firenze, IT 50039 |
| Contact | Alberto Calabro |
| Correspondent | Alberto Calabro FIAB SPA VIA COSTOLI, 4 VICCHIO Firenze, IT 50039 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-22 |
| Decision Date | 2009-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08054242449297 | K091163 | 000 |
| 08054242447859 | K091163 | 000 |
| 08054242447842 | K091163 | 000 |
| 08054242447835 | K091163 | 000 |
| 08054242447828 | K091163 | 000 |
| 08054242447811 | K091163 | 000 |
| 08054242447804 | K091163 | 000 |
| 08054242447798 | K091163 | 000 |