Venturi Mask/Delivery System #'S
FDA 510(k) K810373 · Todd Industries, Inc.
510(k) numberK810373
Submission
- Device name
- Venturi Mask/Delivery System #'S
- Applicant
- Todd Industries, Inc.
Mchenry, IL, US - Received
- February 12, 1981
- Decision date
- March 17, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYF – Mask, Oxygen, Low Concentration, Venturi
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5600
- Specialty
- Anesthesiology
Other 510(k)s with product code BYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955483 | Trach Mask Model (245, 246)BYF · Traditional | Hospitak, Inc. | 02/28/1996SE |
| K951652 | Ventimask MK IVBYF · Traditional | Flexicare Medical, Ltd. | 04/27/1995SE |
| K894457 | Carnation Tracheostomy MasksBYF · Traditional | Dadsun Corp., Ltd. | 10/13/1989SE |
| K860873 | Venturi Mask/Adult & PaediatricBYF · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/20/1986SE |
| K860874 | Venturi Mask W/Humdification Cup Adult/PaediatricBYF · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/19/1986SE |
| K852618 | Oxy-DialBYF · Traditional | Ashai Co. , Ltd. | 09/18/1985SE |
| K832725 | Dual Dial Venturi Style MaskBYF · Traditional | Airlife, Inc. | 09/20/1983SE |
| K812066 | Percento Mask, Pediatric, Under-The-ChinBYF · Traditional | Airlife, Inc. | 08/03/1981SE |
| K810947 | Air Entrainment Trach TBYF · Traditional | Airlife, Inc. | 06/02/1981SE |
| K810946 | Adult & Pediatric Tracheostomy MasksBYF · Traditional | Airlife, Inc. | 06/02/1981SE |
More from Airlife, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K810362 | Corrugated Flex TubingBYX · Traditional | 03/17/1981SE |
| K810361 | Connector AdaptersBZA · Traditional | 03/17/1981SE |
| K810344 | Oxygen TubingBYX · Traditional | 03/17/1981SE |
| K810343 | NebulizersCCQ · Traditional | 03/17/1981SE |
| K810342 | Nasal CannulaCAT · Traditional | 03/17/1981SE |
| K810341 | Lifeline Ippb Set-UpBZO · Traditional | 03/17/1981SE |
| K810340 | Adult Masks & Pediatric MasksBYG · Traditional | 03/17/1981SE |
| K810339 | Noseclip #6118BXJ · Traditional | 03/17/1981SE |
| K810430 | Venturi Mask/Delivery System #6078BYF · Traditional | 03/13/1981SE |
| K810374 | Corrugated Flex Tubing #6000,BYX · Traditional | 03/13/1981SE |
Questions and answers
When was Venturi Mask/Delivery System #'S cleared by the FDA?
Venturi Mask/Delivery System #'S (K810373) received a 510(k) decision of Substantially Equivalent on March 17, 1981, 33 days after the submission was received.
What is the product code of K810373?
The FDA product code is BYF – Mask, Oxygen, Low Concentration, Venturi, a Class I (low risk) device regulated under 21 CFR 868.5600.