SA-3000P
Catalogue number SA-3000P, listed by Medicore Co., Ltd., South Korea, under Plethysmograph, Photoelectric, Pneumatic Or Hydraulic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Raycome Health Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Medicore Co., Ltd., South Korea |
|---|---|
| FDA product code | JOM |
| Device type | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2780 |
| Establishment | Manufacturer |
| 510(k) | K073323 |
| Record published | 2019-04-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 0 to 80 % RH |
| Packaging | Carton |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA-3000P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dopplex | Huntleigh Healthcare Ltd. | 16 |
| Hokanson | D. E. Hokanson, Inc. | 7 |
| Medi | Medi Manufacturing Inc | 6 |
| QuantaFlo | Semler Scientific, Inc. | 5 |
| FloChec | Semler Scientific, Inc. | 3 |
| Doppler Model 1059-C W/PPG | Parks Medical Electronics, Inc. | 2 |
| TBL-ABI | LD Technology LLC | 1 |
| Mesi mTABLET ABI | Mesi D.O.O. | 1 |
| Doppler Model 1050-C W/PPG | Parks Medical Electronics, Inc. | 1 |
| Doppler Model 1058-C W/PPG | Parks Medical Electronics, Inc. | 1 |
| Max Pulse | Medicore Co., Ltd. | 1 |
| Doppler Model 1052-C | Parks Medical Electronics, Inc. | 1 |
Showing 12 of 20. All products under Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110374 | 2011-06-13 |
| K073323 | 2007-11-29 |
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.