510(k) K021605
- Device
- MEDGEM
- Applicant
- HEALTHETECH, INC.
- 510(k) number
- K021605
- Product code
- BZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-06-14
- Date received
- 2002-05-16
- Regulation
- 868.1730
- Classification name
- Computer, Oxygen-uptake
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GLENN M THIBAULT
- Address
- 523 Park Pt. Dr. Golden CO US 80401 80401
FDA Registration Numbers#
- 3009507357
- 3015272694
- 9710602
- 3008264255
- 3013596024
- 3013500228
- 3003288989
- 8020605
- 3013679558
- 3008947133
- 3004055954
- 3012066447
- 1651104
- 8021084
- 3030446844
- 3005877899
- 2023529
- 3008483389
- 3008729547
- 2134715
- 1724967
- 1000604079
- 3004415070
- 9610105
- 3013557562
- 9615102
- 2183022
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BZL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200076 | Breezing Med | Tf Health Co. | 2020-09-25 |
| K190561 | NICU V'02 | Cosmed Nordic Aps | 2020-09-04 |
| K110810 | ANASCIENT BREATH MONITOR | Invoy Technologies, LLC | 2011-06-21 |
| K093080 | METAPHOR METABOLIC MONITOR | Treymed, Inc. | 2010-01-22 |
| K071533 | FITMATE SERIES | Cosmed Srl | 2007-09-28 |
| K070858 | EXPRESS SERIES | Medical Graphics Corp. | 2007-04-16 |
| K061731 | MEDGRAPHICS ULTIMA SYSTEM | Medical Graphics Corp. | 2006-09-06 |
| K021490 | REEVUE INDIRECT CALORIMETER, MODEL#8100 | Korr Medical Technologies, Inc. | 2003-01-02 |
| K010577 | BODYGEM, MODEL HB211 | Healthetech, Inc. | 2002-01-10 |
| K954731 | OXYLOG 2 | P.K. Morgan , Ltd. | 1997-01-06 |
| K924978 | 7250 METABOLIC MONITOR | Puritan Bennett Corp. | 1994-09-22 |
| K921565 | CARDIOPULMONARY METABOLIC MEASUEMENT CART | Quiton Instrument Co. | 1994-08-11 |
| K931422 | DELTATRAC(TM) II METABOLIC MONITOR | Datex Division Instrumentarium Corp. | 1993-11-24 |
| K922660 | PHYSIO-DYNE EASI - LAB | Physio-Dyne | 1993-04-08 |
| K912906 | MEDGRAPHICS PF/DX | Medical Graphics Corp. | 1992-02-04 |
Legacy Summary#
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FDA Review#
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