The following data is part of a premarket notification filed by Med Science with the FDA for Argis Pulmonary Function Testing System.
| Device ID | K921306 |
| 510k Number | K921306 |
| Device Name: | ARGIS PULMONARY FUNCTION TESTING SYSTEM |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | MED SCIENCE 12151 BLACKFOOT TRAIL Jacksonville, FL 32223 |
| Contact | Ted Tabor |
| Correspondent | Ted Tabor MED SCIENCE 12151 BLACKFOOT TRAIL Jacksonville, FL 32223 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-18 |
| Decision Date | 1993-06-25 |