510(k) K790888
- Device
- TRACH T WITH ONE-WAY VALVES
- Applicant
- AIRLIFE, INC.
- 510(k) number
- K790888
- Product code
- BZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-06-27
- Date received
- 1979-05-07
- Regulation
- 868.5810
- Classification name
- Connector, Airway (extension)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010097171
- 3004748541
- 3009490946
- 3030446844
- 3020614
- 3012307300
- 3010580321
- 3010741366
- 3008867836
- 3010272829
- 3014228009
- 3003862188
- 3004111573
- 1219324
- 3031369651
- 3006606984
- 8022265
- 3012316249
- 3006446479
- 3032747418
- 8044169
- 8030229
- 3013501110
- 9617604
- 3017751928
- 3030733800
- 3003431869
- 3008363989
- 3011137372
- 3017202422
- 2020813
- 3005783425
- 9616445
- 8021995
- 3021607937
- 3010834934
- 3009771213
- 3003902679
- 3012250536
- 8044004
- 3006783791
- 9611451
- 3022120197
- 3019545235
- 3011237770
- 3014579161
- 3018783526
- 3018762668
- 3006897516
- 2427500
- 2028807
- 3016634999
- 3000126629
- 3020751316
- 1319639
- 3013507143
- 3023294726
- 1018470
- 1526534
- 9710391
- 3009831876
- 2936999
- 3009291251
- 1824226
- 3016852448
- 9612433
- 3010882708
- 3021244152
- 3007048256
- 3003877407
- 3003898360
- 3023272766
- 3001650535
- 1000484830
- 3017844574
- 3004050971
- 1928237
- 1832562
- 3010838917
- 3018094310
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BZA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K083702 | TRACH-ASSIST | Mergenet Medical | 2009-03-05 |
| K954383 | SURELOC CIRCUIT CONNECTOR | Polamedco, Inc. | 1995-12-22 |
| K954197 | DISPOSABLE FLEX TUBE | Engstrom Medical | 1995-10-26 |
| K953786 | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS | Unicor, Inc. | 1995-09-19 |
| K952824 | NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR | Intertex Medical, Inc. | 1995-07-20 |
| K951345 | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING | Catheter Research, Inc. | 1995-04-14 |
| K944532 | PRIMA, INC. VENTILATOR HOSES | Prima, Inc. | 1994-12-02 |
| K944535 | PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS | Prima, Inc. | 1994-11-29 |
| K944534 | PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS | Prima, Inc. | 1994-11-29 |
| K942392 | AIRWAY CONNECTOR WITH FLEX TUBE | Mallinckrodt Medical | 1994-08-22 |
| K941026 | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | Thayer Medical Corp. | 1994-08-18 |
| K940793 | DOUBLE TRACH SWIVEL CONNECTOR | Seven Harvest Intl. Import & Export | 1994-07-01 |
| K940544 | DOUBLE TRACH SEIVEL CONNECTOR | Fvtnks | 1994-04-19 |
| K935821 | DOUBLE TRACH SWIVEL CONNECTOR | Nutec, Inc. | 1994-01-14 |
| K931800 | MAG CONNECTORS AND AIRWAY EXTENSIONS | Mag, Inc. | 1993-05-19 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases