510(k) K781428
- Device
- FLEXTUBES:9, 20, 26
- Applicant
- BOURNS MEDICAL SYSTEMS, INC.
- 510(k) number
- K781428
- Product code
- BYX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-09-11
- Date received
- 1978-08-21
- Regulation
- 868.5860
- Classification name
- Tubing, Pressure And Accessories
- 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#
- 3004748541
- 3006038729
- 3044994756
- 3008774304
- 3011587055
- 3001421318
- 3009702671
- 3015219237
- 3008439467
- 3012421607
- 3020614
- 3012307300
- 3006157842
- 3010580321
- 1623486
- 3013156250
- 3010272829
- 3008341245
- 3014766741
- 3038139564
- 3003862188
- 3045058049
- 3010042047
- 3005925370
- 3005182235
- 3004111573
- 2025917
- 3031369651
- 3013055504
- 3006606984
- 8022265
- 3008115001
- 3012316249
- 8022978
- 3043051314
- 3032747418
- 3006446479
- 8044169
- 9710644
- 1422598
- 3016746538
- 9616088
- 3004604967
- 3016784019
- 3030733800
- 1058584
- 3011137372
- 3003431869
- 2020813
- 3017202422
- 3008278458
- 9615334
- 2518422
- 3004034546
- 3016723884
- 9616445
- 1017294
- 3008770104
- 3022528821
- 3005998497
- 1043214
- 8021995
- 1529989
- 3007573469
- 8022210
- 3000268902
- 3010834934
- 1526809
- 3009771213
- 3003902679
- 2433012
- 3008688054
- 3006783791
- 9611451
- 3008571754
- 3003924186
- 3007963782
- 3004874794
- 3042970959
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BYX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011134 | OXYGEN SUPPLY TUBING, MODEL 1115 | Hudson Respiratory Care, Inc. | 2001-06-13 |
| K955656 | NORTH STATE PLASTICS AEROSOL TEE | North State Plastics, Inc. | 1996-03-06 |
| K943110 | GAS SAMPLING INTERFACES | Coast Medical, Inc. | 1994-08-19 |
| K935835 | BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES | Busse Hospital Disposables, Inc. | 1994-01-12 |
| K931043 | MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS | Medical Fittings, Inc. | 1993-06-01 |
| K931033 | MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS | Medical Fittings, Inc. | 1993-06-01 |
| K913422 | OXYGEN TUBING, 81503 | Specialty Packaging Producs, Inc. | 1992-01-30 |
| K914980 | HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES | Medical Fittings, Inc. | 1992-01-21 |
| K912763 | OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) | Medical Fittings, Inc. | 1991-10-15 |
| K905091 | VARIOUS MALE QUICK CONNECTS. | Medical Fittings, Inc. | 1991-03-04 |
| K905094 | SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN | Medical Fittings, Inc. | 1990-11-20 |
| K904757 | OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS | Medical Fittings, Inc. | 1990-10-31 |
| K904702 | MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS | Medical Fittings, Inc. | 1990-10-31 |
| K904701 | MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN | Medical Fittings, Inc. | 1990-10-31 |
| K904337 | OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN. | Medical Fittings, Inc. | 1990-10-04 |
Legacy Summary#
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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