The following data is part of a premarket notification filed by Diemolding Corp. with the FDA for Respirex 2.
| Device ID | K900754 |
| 510k Number | K900754 |
| Device Name: | RESPIREX 2 |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | DIEMOLDING CORP. 125 RASBACH ST. Canastota, NY 13032 |
| Contact | Jean Wallace |
| Correspondent | Jean Wallace DIEMOLDING CORP. 125 RASBACH ST. Canastota, NY 13032 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-03-15 |