Aerotel Ltd.
Holon Central, IL
Aerotel Ltd. appears in FDA device records in Holon Central, IL. FDA records list 6 510(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 6 510(k) clearances for Aerotel Ltd. between 1994 and 1998. The busiest year on record is 1995, with 2. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 2 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K980144 | HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER | DXH | Substantially Equivalent | |
| K953762 | HEART 400 ECG TRANSMITTER | DXH | Substantially Equivalent | |
| K961362 | AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE | DXH | Substantially Equivalent | |
| K950004 | HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER | DPS | Substantially Equivalent | |
| K931020 | HEART 1001 | DXH | Substantially Equivalent | |
| K930314 | HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE | DXH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009079475 | 3009079475 | Aerotel Ltd. | 19 Hamashbir Str., Holon Central 58117 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
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Data as of , FDA export datePage updated Source: openFDA, public domain