Welch Allyn, Inc.
PCE-210 PC-Based Exercise Stress System; 12-Lead Stress Test System (includes CardioPerfect workstation software, resting ECG functionality, digital ECG patient cable with USB connection,…
PCE-210 PC-Based Exercise Stress System; 12-Lead Stress Test System (includes CardioPerfect workstation software, resting ECG functionality, digital ECG patient cable with USB connection, treadmill interface cable, stress electrodes and manuals on CD)
10manufacturers in China registered for this device type
47catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Fujian (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Flexible Circuit Technologies Shenzhen | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Feellife Health Inc. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | BZG |
| Device type | Spirometer, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1840 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K082478 |
| Record published | 2016-09-17 |
| Record revised | 2025-08-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2025-08-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901051 | In distribution | |
| 901006 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901007 | In distribution | |
| 901097 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901128 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901050 | In distribution | |
| 901128 | In distribution | |
| 901128 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901051 | In distribution | |
| 901047 | In distribution | |
| 901006 | In distribution | |
| 901128 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901007 | In distribution | |
| 901047 | In distribution | |
| 901051 | In distribution | |
| 901128 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901047 | In distribution | |
| 901051 | Withdrawn | |
| 901047 | Withdrawn | |
| 901047 | Withdrawn | |
| 901051 | Withdrawn | |
| 901007 | Withdrawn | |
| 901047 | Withdrawn | |
| 901047 | Withdrawn | |
| 901006 | Withdrawn | |
| 901047 | Withdrawn | |
| 901047 | Withdrawn | |
| 901051 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Polytech Filter | Polytechnic Resources, Inc. | 190 |
| Model 4000 | Vitalograph Ireland Ltd. | 115 |
| Astra Spirometer | S D I Diagnostics Inc | 90 |
| MIR | Mir Medical International Research | 56 |
| Curaplex | TRI-Anim Health Services, Inc. | 55 |
| Alpha | Vitalograph Ireland Ltd. | 48 |
| MGC Diagnostics | Medical Graphics Corp. | 42 |
| Astraguard | S D I Diagnostics Inc | 39 |
| PFT | Vitalograph Ireland Ltd. | 38 |
| Vyaire | Jaeger Medical GmbH | 36 |
| BVF | Vitalograph Ireland Ltd. | 29 |
| Micro Medical | Jaeger Medical GmbH | 25 |
Showing 12 of 123. All products under Spirometer, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191013 | 2019-09-10 |
| K082478 | 2009-03-09 |
| K052158 | 2005-09-08 |
| K895253 | 1989-11-02 |
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.