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 | K163249 |
| 510k Number | K163249 |
| Device Name: | GoSpiro |
| Classification | Spirometer, Diagnostic |
| Applicant | MONITORED THERAPEUTICS, INC. 5940 VENTURE DR., SUITE C Dublin, OH 43017 |
| Contact | William Zimlich |
| Correspondent | Paul Dryden PROMEDIC, LLC 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-18 |
| Decision Date | 2017-03-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000692823 | K163249 | 000 |
| 00860000692809 | K163249 | 000 |
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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