PFT Calibrator
FDA 510(k) K801597 · Spital Medical, Inc.
510(k) numberK801597
Submission
- Device name
- PFT Calibrator
- Applicant
- Spital Medical, Inc.
Mchenry, IL, US - Received
- June 24, 1980
- Decision date
- August 4, 1980
- 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
Other 510(k)s with product code BZC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240293 | STSBZC · Traditional | Techbopulm, Ltd. | 09/17/2024SE |
| K183567 | Vyntus/SentrySuite Product LineBZC · Traditional | Vyaire Medical | 08/23/2019SE |
| K190853 | Vyntus BODYBZC · Traditional | Vyaire Medical, Inc. | 08/16/2019SE |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…BZC · Traditional | Vyaire Medical, Inc. | 11/30/2018SE |
| K162515 | COSMED K5 Wearable Metabolic TechnologyBZC · Traditional | Cosmed Srl | 06/20/2017SE |
| K161295 | MiniBox +BZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 10/21/2016SE |
| K150810 | Vyntus / SentrySuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/14/2015SE |
| K133925 | Vyntus/ Sentrysuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/22/2014SE |
| 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 |
Questions and answers
When was PFT Calibrator cleared by the FDA?
PFT Calibrator (K801597) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 41 days after the submission was received.
What is the product code of K801597?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.