Metabolic Exercise Testing System
FDA 510(k) K831780 · Warren E. Collins, Inc.
510(k) numberK831780
Submission
- Device name
- Metabolic Exercise Testing System
- Applicant
- Warren E. Collins, Inc.
Walker, MI, US - Received
- June 2, 1983
- Decision date
- September 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZL – Computer, Oxygen-Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1730
- Specialty
- Anesthesiology
Other 510(k)s with product code BZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200076 | Breezing MedBZL · Traditional | Tf Health Co. | 09/25/2020SE |
| K190561 | Nicu V'02BZL · Traditional | Cosmed Nordic Aps | 09/04/2020SE |
| K110810 | Anascient Breath MonitorBZL · Traditional | Invoy Technologies, LLC | 06/21/2011SE |
| K093080 | Metaphor Metabolic MonitorBZL · Traditional | Treymed, Inc. | 01/22/2010SE |
| K071533 | Fitmate SeriesBZL · Traditional | Cosmed Srl | 09/28/2007SE |
| K070858 | Express SeriesBZL · Special | Medical Graphics Corp. | 04/16/2007SE |
| K061731 | Medgraphics Ultima SystemBZL · Special | Medical Graphics Corp. | 09/06/2006SE |
| K021490 | Reevue Indirect Calorimeter, MODEL#8100BZL · Traditional | Korr Medical Technologies, Inc. | 01/02/2003SE |
| K021605 | MedgemBZL · Special | Healthetech, Inc. | 06/14/2002SE |
| K010577 | Bodygem, Model HB211BZL · Traditional | Healthetech, Inc. | 01/10/2002SE |
More from Healthetech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925459 | Gs-Modular (Gold Standard - Modular)BZG · Traditional | 02/04/1994SE |
| K912946 | Collins Digital Pulmonary ManometerBXR · Traditional | 01/15/1992SE |
| K871151 | The Spira Elektro 2CCQ · Traditional | 05/15/1987SE |
| K861227 | Collins Pneumotach PFT SystemBZG · Traditional | 06/05/1986SE |
| K852102 | Collin Body Plethysmograph Plus SystemCCM · Traditional | 07/31/1985SE |
| K831778 | Rs-Residual Volume SystemBZC · Traditional | 08/31/1983SE |
| K831777 | Collins DSBZC · Traditional | 08/31/1983SE |
| K831779 | Collins Eagle IIBZC · Traditional | 08/26/1983SE |
| K803069 | Shell Kraton Thermo-Plastic Rubber Comp.BYP · Traditional | 12/22/1980SE |
| K803053 | Apexline of Pulmonary Funct. Instrum.BTY · Traditional | 12/22/1980SE |
Questions and answers
When was Metabolic Exercise Testing System cleared by the FDA?
Metabolic Exercise Testing System (K831780) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 102 days after the submission was received.
What is the product code of K831780?
The FDA product code is BZL – Computer, Oxygen-Uptake, a Class II (moderate risk) device regulated under 21 CFR 868.1730.