3 catalogue numbers from V-375119-03, listed by Jaeger Medical GmbH, Germany, under Calculator, Pulmonary Function Data. 1 manufacturer in China is registered for this product code.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for APS-Pro SA | Listed by | Jaeger Medical GmbH, Germany |
| FDA product code | BZC |
| Device type | Calculator, Pulmonary Function Data |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1880 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K001502 |
| Record published | 2017-04-10 |
| Record revised | 2025-09-24 (version 9) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 50 °C; Storage environment humidity 15 to 95 % RH |
| Distribution end date | 2019-05-20 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
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.