FDA Registration
Active
🇺🇸 United States
MONITORED THERAPEUTICS, INC.
Reg #: 3012250536
·
FEI: 3012250536
·
Expires 2026
Products
8
Proprietary Names
21
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- MONITORED THERAPEUTICS, INC.
- Registration Number
- 3012250536
- FEI Number
- 3012250536
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5160 Blazer Parkway
- City
- Dublin
- State
- OH
- ZIP
- 43017
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183369
Owner / Operator
- Firm Name
- Monitored Therapeutics, Inc.
- Operator Number
- 10050970
- Address
- 1730 Michael Lane
- City
- Pacific Palisades
- State
- CA
- Postal Code
- 90272
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2019-01-31 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2020-12-29 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2024-01-03 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2021-09-07 |
| Device, Rebreathing | BYW | Class 1 | Anesthesiology | No | 2025-02-02 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2016-01-21 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2025-02-02 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2023-08-13 |
Proprietary Names
GoECG
GoSpiro
GoSpiro Mouthport Adapter
Adapter, 30mm ID to 22mm OD
Rebreathing Tube
GoHome
Six Minute Walk Test 6MWT
GoClinic
GoClinic 6MWT
6MWT Six Minute Walk Test
CliniSphere
GoMobile
Hi-Ox High Oxygen Mask
Hi-Ox
Hi-Ox
Parallel-R Nose Clip
GoSpiro Nose Clip
Parallel
Parallel-R
Parallel Nose Clip
MGC Nose Clip
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility