The following data is part of a premarket notification filed by Medical Equipment Designs, Inc. with the FDA for Microspiro-sds.
| Device ID | K851277 |
| 510k Number | K851277 |
| Device Name: | MICROSPIRO-SDS |
| Classification | Spirometer, Diagnostic |
| Applicant | MEDICAL EQUIPMENT DESIGNS, INC. 23461 RIDGE ROUTE DR., SUITE F Laguna Hills, CA 92653 |
| Contact | Michael Berg |
| Correspondent | Michael Berg 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 | 1985-04-01 |
| Decision Date | 1985-04-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MICROSPIRO-SDS 73576389 1407577 Dead/Cancelled |
MEDICAL EQUIPMENT DESIGNS INC. 1986-01-06 |