The following data is part of a premarket notification filed by Medical Systems Corp. with the FDA for Spirolite Model Msc-201 Spirometer.
| Device ID | K921513 |
| 510k Number | K921513 |
| Device Name: | SPIROLITE MODEL MSC-201 SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | MEDICAL SYSTEMS CORP. ONE PLAZA RD. Greenvale, NY 11548 -9801 |
| Contact | Mardin Varela |
| Correspondent | Mardin Varela MEDICAL SYSTEMS CORP. ONE PLAZA RD. Greenvale, NY 11548 -9801 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-31 |
| Decision Date | 1993-01-27 |