The following data is part of a premarket notification filed by Medical Equipment Designs, Inc. with the FDA for Multispiro.
| Device ID | K895375 |
| 510k Number | K895375 |
| Device Name: | MULTISPIRO |
| Classification | Spirometer, Diagnostic |
| Applicant | MEDICAL EQUIPMENT DESIGNS, INC. 23461 RIDGE ROUTE DR., SUITE F Laguna Hills, CA 92653 |
| Contact | Richard Rosenthal |
| Correspondent | Richard Rosenthal MEDICAL EQUIPMENT DESIGNS, INC. 23461 RIDGE ROUTE DR., SUITE F Laguna Hills, CA 92653 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-30 |
| Decision Date | 1989-11-27 |