I-Tech Industries SRL
Bologna Bologna, IT
I-TECH INDUSTRIES SRL appears in FDA device records in Bologna Bologna, IT. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for I-Tech Industries SRL between 1987 and 2021. The busiest year on record is 1987, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1988 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | NUV | Substantially Equivalent | |
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) | NUV | Substantially Equivalent | |
| K875319 | NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS | GEN | Substantially Equivalent | |
| K874634 | NSN #6515-00-333-2400 ADSON DRESSING FORCEPS | GEN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013517454 | 3013517454 | I-TECH INDUSTRIES SRL | Via I Maggio 4/Q, Bologna 40057 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain