2 JET SET
FDA 510(k) clearance K771385 · decided 1977-08-04
Clearance details
- K-number
- K771385
- Device name
- 2 JET SET
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1977-07-27
- Decision date
- 1977-08-04
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- BYF
- Device class
- 1
- Regulation number
- 868.5600
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Washington, DC, US
- 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 |
| VENTIMASK MK IV (K951652) | Flexicare Medical, Ltd. | 1995-04-27 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |