Lotus Pulmonary Function Filter, Models CPF 101, CPF 102, CPF 103
FDA 510(k) K033518 · Custom Plastic Products
510(k) numberK033518
Submission
- Device name
- Lotus Pulmonary Function Filter, Models CPF 101, CPF 102, CPF 103
- Applicant
- Custom Plastic Products
Laguna Niguel, CA, US - Received
- November 7, 2003
- Decision date
- March 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
Other 510(k)s with product code BZG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251777 | MESI mTABLET SPIROBZG · Traditional | Mesi D.O.O. | 03/02/2026SE |
| K241843 | TD-7301 Spirometer (TD-7301)BZG · Traditional | Gostar Co., Ltd. | 11/20/2024SE |
| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
| K230501 | Spirobank OxiBZG · Traditional | Mir Medical International Research USA | 12/15/2023SE |
| K230178 | EasyOne Sky SpirometerBZG · Traditional | Ndd Medizintechnik AG | 10/19/2023SE |
| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
| K222443 | Air Smart Extra SpirometerBZG · Traditional | Feellife Health, Inc. | 08/09/2023SE |
| K213754 | SpiroHome Personal, SpiroHome ClinicBZG · Traditional | Inofab Saglik Teknolojileri A.S | 06/12/2023SE |
| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
Questions and answers
When was Lotus Pulmonary Function Filter, Models CPF 101, CPF 102, CPF 103 cleared by the FDA?
Lotus Pulmonary Function Filter, Models CPF 101, CPF 102, CPF 103 (K033518) received a 510(k) decision of Substantially Equivalent on March 10, 2004, 124 days after the submission was received.
What is the product code of K033518?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.