Spirotrac
Spirometer, Diagnostic
Vitalograph Ireland Ltd.
The following data is part of a premarket notification filed by Vitalograph Ireland Ltd. with the FDA for Spirotrac.
Pre-market Notification Details
| Device ID | K201562 |
| 510k Number | K201562 |
| Device Name: | Spirotrac |
| Classification | Spirometer, Diagnostic |
| Applicant | Vitalograph Ireland Ltd. Gort Road Business Park Ennis Co Clare, IE V95 Hft4 |
| Contact | Tony O'hanlon |
| Correspondent | Paul Dryden Vitalograph Ireland Ltd. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-10 |
| Decision Date | 2020-10-14 |
Trademark Results [Spirotrac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIROTRAC 75228785 2215740 Live/Registered |
Vitalograph Limited 1997-01-21 |
 SPIROTRAC 74474724 not registered Dead/Abandoned |
Healthdyne Technologies, Inc. 1993-12-30 |
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