PF 5010 Ldpm Unit
Catalogue number PF 5010, listed by Perimed AB, Sweden, under Flowmeter, Blood, Cardiovascular. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
| Dongguan Mars Medical Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 9 |
| Onbo Electronic (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Perimed AB, Sweden |
|---|---|
| FDA product code | DPW |
| Device type | Flowmeter, Blood, Cardiovascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2100 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K974285 |
| Record published | 2018-12-11 |
| Record revised | 2023-02-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 30 to 85 % RH; Storage environment temperature 0 to 50 °C |
| Distribution end date | 2023-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PF 5010 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transonic | Transonic Systems, Inc. | 627 |
| SonoTT Vascular Probe | Em-Tec GmbH | 12 |
| BiDop 7 probe | Koven Technology, Inc. | 8 |
| Medistim MiraQ Cardiac System | Medistim ASA | 6 |
| Medistim MiraQ Vascular System | Medistim ASA | 6 |
| FlowMet™ | Medtronic, Inc. | 4 |
| GEM Flow Coupler | Synovis Micro Companies Alliance | 4 |
| CooperSurgical® | Coopersurgical, Inc. | 4 |
| Medistim System Activation Card | Medistim ASA | 3 |
| 811-BL 24V Foreign & Domestic | Parks Medical Electronics, Inc. | 3 |
| Medistim MiraQ Ultimate System | Medistim ASA | 3 |
| Dopplex | Huntleigh Healthcare Ltd. | 3 |
Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152930 | 2016-05-05 |
| K011899 | 2001-11-06 |
| K974285 | 1998-05-28 |
| K932068 | 1993-12-07 |
| K922368 | 1993-02-03 |
| K890828 | 1989-06-20 |
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.