Flow Reducing Angulation Stand
FDA 510(k) K780265 · Chesebrough-Pond'S U.S.A. Co.
510(k) numberK780265
Submission
- Device name
- Flow Reducing Angulation Stand
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
Mchenry, IL, US - Received
- February 17, 1978
- Decision date
- March 9, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
Other 510(k)s with product code BWF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241152 | InSeeBWF · Traditional | Tidal Medical Technologies, LLC | 08/21/2025SE |
| K233855 | AllPEPBWF · Traditional | Enchant Tek Co. , Ltd. | 02/02/2024SE |
| K221058 | LungTrainer (MD2 & MD3)BWF · Traditional | Lung Trainers, LLC | 07/05/2023SE |
| K222018 | Breathe+BWF · Traditional | Peep Medical, LLC Dba Go2 Devices | 06/02/2023SE |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional | Medline Industries, Inc. | 10/25/2022SE |
| K203378 | PulsehalerBWF · Traditional | Respinova, Ltd. | 03/31/2021SE |
| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
| K181660 | Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional | Smiths Medical | 10/24/2019SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | Trudell Medical International | 08/16/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | Teleflexmedical, Inc. | 07/01/2019SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863866 | Respiradyne Ii(Tm)BZK · Traditional | 01/28/1987SE |
| K862803 | Chesebrough Pond's Hydrocolloid DressingFRO · Traditional | 11/14/1986SN |
| K851383 | Blisterfilm Transparent DressingNAD · Traditional | 07/05/1985SN |
| K851382 | Chesebrough-Pond's Sequential Wound DressingNAD · Traditional | 07/05/1985SN |
| K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloKNT · Traditional | 06/12/1985SE |
| K843567 | Kangaroo Nasogastric Feeding TubeKNT · Traditional | 02/14/1985SE |
| K845010 | Chesebrough-Pond's Uri-Drain Male Urinary PouchEYQ · Traditional | 01/15/1985SE |
| K844186 | Continent Stoma System & AccessoriesKBG · Traditional | 01/15/1985SE |
| K844789 | Kangaroo Access II Enteral Feeding ContainerKNT · Traditional | 01/02/1985SE |
| K843128 | Female Urinary Incontinence SysKNX · Traditional | 01/02/1985SE |
Questions and answers
When was Flow Reducing Angulation Stand cleared by the FDA?
Flow Reducing Angulation Stand (K780265) received a 510(k) decision of Substantially Equivalent on March 9, 1978, 20 days after the submission was received.
What is the product code of K780265?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.