FDA Registration
Active
🇺🇸 United States
Norav Medical Inc.
Reg #: 3008977358
·
FEI: 3008977358
·
Expires 2026
Products
3
Proprietary Names
30
Establishment Types
2
Classifications
3
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Registration Details
- Registration Name
- Norav Medical Inc.
- Registration Number
- 3008977358
- FEI Number
- 3008977358
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1300 Wallace Dr
- City
- Delray Beach
- State
- FL
- ZIP
- 33444
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080141
Owner / Operator
- Firm Name
- NORAV MEDICAL
- Operator Number
- 9024500
- Address
- 4 HAMADA ST., --
- City
- YOKNEAM
- State
- IL-NOTA
- Postal Code
- 2069202
- Country
- IL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2008-04-30 |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | Class 2 | Cardiovascular | No | 2011-12-14 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2016-11-01 |
Proprietary Names
PCECG 1200W
PCECG 1200WR
Advanced wireless PC based ECG
Blue-ECG
NM-700BT
ECGBT2
NH4
NH4a
NH-301-0
NH-301 Ambulatory ECG Analysis Software
NR-1207, NR-1207-3, NR-1207-E, NR-302, NR-314, NR-314-T. NR-314P
NORAV HOLTER ANALYSIS SYSTEM
NH300
Norav Event Recorder (NER)
Norav Medical GmbH
PCECG-1200System with MEANS Interpretation (I3)
PCECG 1200T-03-05-MG
NHH1200
PC-ECG 1200M
ECGUSB1D-EX
PC-ECG 1200S
ECGUSB-1
PC-ECG 1200
Norav ECG Management System (NEMS)
PC-ECG 1200HR
Advanced PC Based ECG System
PC-ECG 1200T
ECGUSB1D-EXR
ECG-LAN (GREEN)
PCECG 1200T (Rev. 03)
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198