510(k) K943110
- Device
- GAS SAMPLING INTERFACES
- Applicant
- COAST MEDICAL, INC.
- 510(k) number
- K943110
- Product code
- BYX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-08-19
- Date received
- 1994-06-29
- Regulation
- 868.5860
- Classification name
- Tubing, Pressure And Accessories
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DOUGLAS R MONGEON
- Address
- 1060-H N. Batavia Orange CA US 92867 92867
FDA Registration Numbers#
- 1450997
- 2954963
- 3009350878
- 1417592
- 3007740622
- 3011224453
- 3006677911
- 3006157842
- 8022978
- 3004491689
- 3006783791
- 1314417
- 3029906224
- 3003767629
- 1529989
- 3010387558
- 3004111573
- 3004748541
- 3005669815
- 3008341245
- 3010272829
- 3032747418
- 3006563173
- 3015168843
- 3014499739
- 3004365956
- 3030733800
- 9710644
- 3013156250
- 3018762668
- 3007305485
- 3007963782
- 1836161
- 3015191173
- 1063382
- 3004605321
- 3008774304
- 3008115001
- 3014273557
- 3014624980
- 2518157
- 3005012805
- 2936485
- 3006897996
- 3006547005
- 3011191255
- 3014766741
- 2032273
- 3016195240
- 8022265
- 3010287621
- 3030152374
- 3005347827
- 3024290085
- 3009756153
- 1313525
- 3008603863
- 3003481016
- 3010595915
- 2023529
- 3017886332
- 3002807267
- 3010202439
- 3020751316
- 1419185
- 1924066
- 3008770104
- 3016746538
- 2028411
- 3010547268
- 2020813
- 3004874794
- 3003902679
- 3008571754
- 1526809
- 3009747810
- 3042256998
- 3010838917
- 3014342096
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 |
| K935835 | BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES | Busse Hospital Disposables, Inc. | 1994-01-12 |
| K931033 | MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS | Medical Fittings, Inc. | 1993-06-01 |
| K931043 | MF OHMEDA 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 |
| K904701 | MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN | Medical Fittings, Inc. | 1990-10-31 |
| K904702 | MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS | Medical Fittings, Inc. | 1990-10-31 |
| K904757 | OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS | Medical Fittings, Inc. | 1990-10-31 |
| K904337 | OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN. | Medical Fittings, Inc. | 1990-10-04 |
| K901961 | OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER | Medical Fittings, Inc. | 1990-08-14 |
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