Spirometric Computer #SC-10
FDA 510(k) K802928 · Cavitron Corp.
510(k) numberK802928
Submission
- Device name
- Spirometric Computer #SC-10
- Applicant
- Cavitron Corp.
Mchenry, IL, US - Received
- November 19, 1980
- Decision date
- December 17, 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 |
More from Innovision A/S
| 510(k) | Device | Decision |
|---|---|---|
| K811582 | The PlacerEID · Traditional | 07/28/1981SE |
| K810207 | Minor Surgery LightGBC · Traditional | 02/13/1981SE |
| K801623 | Cavitron Ultrasonic Surg. Aspir. CusaLFL · Traditional | 11/18/1980SE |
| K801877 | Slit Lamp AttachmentHQB · Traditional | 09/16/1980SE |
| K800869 | Model PM-20(N)(R)CO2 Patient Monitor/AlaCCK · Traditional | 05/28/1980SE |
| K800722 | Auto-Field D Automated Visual DetectorHPT · Traditional | 04/29/1980SE |
| K791585 | Model G-61 Ultrasonic Dental UnitELC · Traditional | 09/19/1979SE |
| K791277 | Model 6500 Extraction Irrigation SysHDQ · Traditional | 08/22/1979SE |
| K782054 | Laser, CO2 SurgicalHHR · Traditional | 01/17/1979SE |
| K782065 | Laser, PhotocoagulationHQF · Traditional | 12/28/1978SE |
Questions and answers
When was Spirometric Computer #SC-10 cleared by the FDA?
Spirometric Computer #SC-10 (K802928) received a 510(k) decision of Substantially Equivalent on December 17, 1980, 28 days after the submission was received.
What is the product code of K802928?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.