The following data is part of a premarket notification filed by Hougen Mfg., Inc. with the FDA for Mini-ciser.
| Device ID | K974848 |
| 510k Number | K974848 |
| Device Name: | MINI-CISER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | HOUGEN MFG., INC. 3001 HOUGEN DR. Swartz Creek, MI 48473 |
| Contact | Jeffery R Miller |
| Correspondent | Jeffery R Miller HOUGEN MFG., INC. 3001 HOUGEN DR. Swartz Creek, MI 48473 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-08-06 |
| Summary: | summary |