The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Pul-tron 100k Professional Spirometer.
| Device ID | K891672 |
| 510k Number | K891672 |
| Device Name: | PUL-TRON 100K PROFESSIONAL SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. C/O C. G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy ADVANTAGE MEDICAL SYSTEMS, INC. C/O C. G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-21 |
| Decision Date | 1989-06-16 |