Apexline of Pulmonary Funct. Instrum.
FDA 510(k) K803053 · Warren E. Collins, Inc.
510(k) numberK803053
Submission
- Device name
- Apexline of Pulmonary Funct. Instrum.
- Applicant
- Warren E. Collins, Inc.
Mchenry, IL, US - Received
- December 2, 1980
- Decision date
- December 22, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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| 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 |
| 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 |
Questions and answers
When was Apexline of Pulmonary Funct. Instrum. cleared by the FDA?
Apexline of Pulmonary Funct. Instrum. (K803053) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 20 days after the submission was received.
What is the product code of K803053?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.