The following data is part of a premarket notification filed by Med Science with the FDA for Exersystem(tm) Mmc 5000.
| Device ID | K864911 |
| 510k Number | K864911 |
| Device Name: | EXERSYSTEM(TM) MMC 5000 |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | MED SCIENCE 1455 PAGE INDUSTRIAL BLVD. St. Louis, MO 63132 |
| Contact | Norman E Rowe |
| Correspondent | Norman E Rowe MED SCIENCE 1455 PAGE INDUSTRIAL BLVD. St. Louis, MO 63132 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1987-08-21 |