GoSpiro
Spirometer, Diagnostic
Monitored Therapeutics, Inc.
The following data is part of a premarket notification filed by Monitored Therapeutics, Inc. with the FDA for Gospiro.
Pre-market Notification Details
| Device ID | K202837 |
| 510k Number | K202837 |
| Device Name: | GoSpiro |
| Classification | Spirometer, Diagnostic |
| Applicant | Monitored Therapeutics, Inc. 5995 Shier Rings Road, Ste A Dublin, OH 43016 |
| Contact | Michael Taylor |
| Correspondent | Paul Dryden Monitored Therapeutics, Inc. C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2020-12-04 |
Trademark Results [GoSpiro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GOSPIRO 86433412 4947132 Live/Registered |
MONITORED THERAPEUTICS, INC. 2014-10-24 |
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