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 |