Norav Medical Ltd.
Delray Beach, FL, US
NORAV MEDICAL LTD. appears in FDA device records in Delray Beach, FL. FDA records list 6 510(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 6 510(k) clearances for Norav Medical Ltd. between 2000 and 2016. The busiest year on record is 2011, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2002 | 1 |
| 2008 | 1 |
| 2011 | 2 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161062 | NR Recorder | MWJ | Substantially Equivalent | |
| K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | MLO | Substantially Equivalent | |
| K110463 | PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) | MWI | Substantially Equivalent | |
| K080141 | PC ECG 1200W SYSTEM | MWI | Substantially Equivalent | |
| K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | MLO | Substantially Equivalent | |
| K000404 | PC ECG 1200 | MWI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681548 | 3002807745 | NORAV MEDICAL LTD. | 4 HAMADA ST., YOKNEAM Northern 20692 IL | 2026 | |
| 3008977358 | 3008977358 | Norav Medical Inc. | 1300 Wallace Dr, Delray Beach, FL 33444 US | 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