Rs-Residual Volume System
FDA 510(k) K831778 · Warren E. Collins, Inc.
510(k) numberK831778
Submission
- Device name
- Rs-Residual Volume System
- Applicant
- Warren E. Collins, Inc.
Mchenry, IL, US - Received
- June 2, 1983
- Decision date
- August 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
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| K150810 | Vyntus / SentrySuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/14/2015SE |
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| K133051 | Pulmone Minibox PFT TMBZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 05/02/2014SE |
| K102047 | Lci Option for InnocorBZC · Traditional | Innovision A/S | 11/01/2011SE |
More from Innovision A/S
| 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 |
| K831780 | Metabolic Exercise Testing SystemBZL · Traditional | 09/12/1983SE |
| 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 Rs-Residual Volume System cleared by the FDA?
Rs-Residual Volume System (K831778) received a 510(k) decision of Substantially Equivalent on August 31, 1983, 90 days after the submission was received.
What is the product code of K831778?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.