FDA Registration
Active
🇺🇸 United States
ZOLL MEDICAL CORPORATION
Reg #: 3038259592
·
FEI: 3038259592
·
Expires 2026
Products
12
Proprietary Names
8
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- ZOLL MEDICAL CORPORATION
- Registration Number
- 3038259592
- FEI Number
- 3038259592
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 38 Upton Dr
- City
- Wilmington
- State
- MA
- ZIP
- 01887
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162832
- PMA Number
- P160015
Owner / Operator
- Firm Name
- ZOLL Medical Corporation
- Operator Number
- 1220908
- Address
- 269 MILL ROAD
- City
- Chelmsford
- State
- MA
- Postal Code
- 01824
- Country
- US
- Correspondent
- Paul Dias
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Gas Flow | BXP | Class 1 | Anesthesiology | No | 2026-05-12 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2017-09-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2017-09-18 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2017-05-17 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2017-05-31 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-11-09 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-11-09 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-11-09 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2022-11-09 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2022-11-09 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-11-09 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2022-11-09 |
Proprietary Names
ACCUVENT SENSOR DISPOSABLE
FLOWTUBE, ACCUVENT
FLOW SENSOR CONNECTOR, ACCUVENT
Eagle II
AEV
EMV+
731 Series
Z Vent
Establishment Types
Repack or Relabel Medical Device