Moor Instruments Ltd
moorLDI2 - Laser Doppler Imager (>= S/N 5700)
2manufacturers in China registered for this device type
3catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| RWD Life Science Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Moor Instruments Ltd., United Kingdom |
|---|---|
| FDA product code | DPT |
| Device type | Probe, Blood-Flow, Extravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2120 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K152749 |
| Record published | 2016-07-08 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 86 to 106 KiloPascal; Handling environment humidity 20 to 80 % RH; Handling environment temperature 15 to 30 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 80 % RH; Storage environment temperature 5 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| moorLDI2 | In distribution | |
| moorLDLS | In distribution | |
| moorFLPI2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medex | ICU Medical, Inc | 138 |
| Bio-Probe™ | Medtronic, Inc. | 21 |
| Probe, Blood-Flow, Extravascular | Medtronic, Inc. | 10 |
| Trillium™ Bio-Probe® | Medtronic, Inc. | 2 |
| Trillium™ | Medtronic, Inc. | 2 |
| FloProbe 3/8’’ x 3/8” (Non Sterile) | Movair, Inc. | 1 |
| FloProbe 1/4’’ x 1/4″ (Non Sterile) | Movair, Inc. | 1 |
| FloProbe 1/4’’ x 1/4’’ (Sterile) | Movair, Inc. | 1 |
| I2P24 Doppler Probe | Deltex Medical Limited | 1 |
| I2S6 Doppler Probe | Deltex Medical Limited | 1 |
| moorFLPI-2 Review PC Software | Moor Instruments Ltd. | 1 |
| moorFLPI2- Measurement PC Software | Moor Instruments Ltd. | 1 |
Showing 12 of 17. All products under Probe, Blood-Flow, Extravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152749 | 2016-05-12 |
| K132163 | 2014-01-29 |
| K122943 | 2013-01-03 |
| K060976 | 2007-03-27 |
| K063586 | 2007-01-25 |
| K063561 | 2007-01-19 |
| K032841 | 2003-12-10 |
| K980383 | 1998-04-30 |
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.