Elmed Incorporated
PARK MED - PROBE, DOPPLER, SKINNY PENCIL, 9.0mhz
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Elmed, Inc., United States |
|---|---|
| FDA product code | DYC |
| Device type | Vectorcardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2400 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMP9.2 | In distribution | |
| 832-2900-11 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K810529 | 1981-04-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.