Bioview
Billerica, MA, US
BIOVIEW appears in FDA device records in Billerica, MA. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. 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 5 510(k) clearances for Bioview between 2003 and 2014. The busiest year on record is 2003, with 1. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130775 | DUET SYSTEM | NTH | Substantially Equivalent | |
| K061602 | DUET SYSTEM | JOY | Substantially Equivalent | |
| K050840 | MODIFICATION TO DUET SYSTEM | JOY | Substantially Equivalent | |
| K040591 | DUET SYSTEM | JOY | Substantially Equivalent | |
| K030192 | DUET SYSTEM | JOY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003834059 | 3003834059 | BIOVIEW | 44 MANNING RD STE 4, Billerica, MA 01821 US | 2026 | No device listings on this registration |
| 3003909093 | 3003909093 | BIOVIEW LTD. | 3 PAKRIS STREET, REHOVOT Central 76702 IL | 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
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain