The following data is part of a premarket notification filed by Medical Equipment Designs, Inc. with the FDA for Chestac-25f Spirometer.
Device ID | K840908 |
510k Number | K840908 |
Device Name: | CHESTAC-25F SPIROMETER |
Classification | Spirometer, Diagnostic |
Applicant | MEDICAL EQUIPMENT DESIGNS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-29 |
Decision Date | 1984-05-14 |