VENTIMASK MK IV
FDA 510(k) clearance K951652 · decided 1995-04-27
Clearance details
- K-number
- K951652
- Device name
- VENTIMASK MK IV
- Applicant
- Flexicare Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-10
- Decision date
- 1995-04-27
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- BYF
- Device class
- 1
- Regulation number
- 868.5600
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Somerset, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TRACH MASK MODEL (245, 246) (K955483) | Hospitak, Inc. | 1996-02-28 |
| CARNATION TRACHEOSTOMY MASKS (K894457) | Dadsun Corp., Ltd. | 1989-10-13 |
| VENTURI MASK/ADULT & PAEDIATRIC (K860873) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC (K860874) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| OXY-DIAL (K852618) | Ashai Co. , Ltd. | 1985-09-18 |
| DUAL DIAL VENTURI STYLE MASK (K832725) | Airlife, Inc. | 1983-09-20 |
| PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN (K812066) | Airlife, Inc. | 1981-08-03 |
| AIR ENTRAINMENT TRACH T (K810947) | Airlife, Inc. | 1981-06-02 |
| ADULT & PEDIATRIC TRACHEOSTOMY MASKS (K810946) | Airlife, Inc. | 1981-06-02 |
| VENTURI MASK/DELIVERY SYSTEM #'S (K810373) | Todd Industries, Inc. | 1981-03-17 |
| VENTURI MASK/DELIVERY SYSTEM #6078 (K810430) | Todd Industries, Inc. | 1981-03-13 |
| MASK, PERCENTO (K790146) | Airlife, Inc. | 1979-02-06 |
Recalls involving this device
No recalls on record reference this clearance.