The following data is part of a premarket notification filed by Integrated Medical Systems, Inc. with the FDA for Multimed (tm) Pulmonary Function Testing System.
| Device ID | K895414 |
| 510k Number | K895414 |
| Device Name: | MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM |
| Classification | Spirometer, Diagnostic |
| Applicant | INTEGRATED MEDICAL SYSTEMS, INC. 15000 W. 6TH AVE. Golden, CO 80401 |
| Contact | Mary Schroeder |
| Correspondent | Mary Schroeder INTEGRATED MEDICAL SYSTEMS, INC. 15000 W. 6TH AVE. Golden, CO 80401 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-01 |
| Decision Date | 1990-02-12 |