CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor Hand Held Respiratory Mechanics Mo
FDA 510(k) K982487 · Cardiopulmonary Technologies, Inc.
510(k) numberK982487
Submission
- Device name
- CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor Hand Held Respiratory Mechanics Mo
- Applicant
- Cardiopulmonary Technologies, Inc.
Colgate, WI, US - Received
- July 17, 1998
- Decision date
- October 14, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor Hand Held Respiratory Mechanics Mo cleared by the FDA?
CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor Hand Held Respiratory Mechanics Mo (K982487) received a 510(k) decision of Substantially Equivalent on October 14, 1998, 89 days after the submission was received.
What is the product code of K982487?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.