MEDGEM
Computer, Oxygen-uptake
HEALTHETECH, INC.
The following data is part of a premarket notification filed by Healthetech, Inc. with the FDA for Medgem.
Pre-market Notification Details
| Device ID | K021605 |
| 510k Number | K021605 |
| Device Name: | MEDGEM |
| Classification | Computer, Oxygen-uptake |
| Applicant | HEALTHETECH, INC. 523 PARK POINT DR. Golden, CO 80401 |
| Contact | Glenn M Thibault |
| Correspondent | Glenn M Thibault HEALTHETECH, INC. 523 PARK POINT DR. Golden, CO 80401 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-16 |
| Decision Date | 2002-06-14 |
Trademark Results [MEDGEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDGEM 76283903 2637200 Live/Registered |
MICROLIFE MEDICAL HOMES SOLUTIONS INC. 2001-07-11 |
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