FDA Registration
Inactive
🇺🇸 United States
SMWMED INC.
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMWMED INC.
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9920 Pacific Heights Blvd Ste 410
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252389
Owner / Operator
- Firm Name
- Smwmed Inc.
- Operator Number
- 10095826
- Address
- 9920 Pacific Heights Blvd Ste 410
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Bo Pi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2026-05-06 |
Proprietary Names
Rhythm Master ECG Patch (Models: HM-15BB-AX, HM-15BW-AX)
Establishment Types
Complaint File Establishment per 21 CFR 820.198