FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYMIZER FLOW RESTRICTOR
K Number: K841901
·
Decision Jul 23, 1984
Classifications
1
FEI Numbers
233
Registration Numbers
233
Same Product Code
61
Applicant Total
17
Review Days
77
Basic Information
- Device Name
- OXYMIZER FLOW RESTRICTOR
- K Number
- K841901
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- CHAD THERAPEUTICS, INC.
- Date Received
- May 7, 1984
- Decision Date
- July 23, 1984
- Product Code
- BYX
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYX), ordered by most recent decision date.
OXYGEN SUPPLY TUBING, MODEL 1115
FDA 510(k)
FDA Class 1
·Anesthesiology
NORTH STATE PLASTICS AEROSOL TEE
FDA 510(k)
FDA Class 1
·Anesthesiology
GAS SAMPLING INTERFACES
FDA 510(k)
FDA Class 1
·Anesthesiology
BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
FDA 510(k)
FDA Class 1
·Anesthesiology
MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS
FDA 510(k)
FDA Class 1
·Anesthesiology
MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by CHAD THERAPEUTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K081176 | FLOCHANNEL | Jul 28, 2008 | Substantially Equivalent |
| K070740 | CHAD THERAPEUTICS BONSAI MODEL 800 | May 7, 2007 | Substantially Equivalent |
| K042142 | CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S | Sep 20, 2004 | Substantially Equivalent |
| K033364 | CHAD THERAPEUTICS SAGE | May 11, 2004 | Substantially Equivalent |
| K020475 | CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 | Jul 5, 2002 | Substantially Equivalent |
| K013472 | TOTAL O2 | Nov 28, 2001 | Substantially Equivalent |
| K010389 | CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 | Mar 23, 2001 | Substantially Equivalent |
| K003455 | MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 | Dec 6, 2000 | Substantially Equivalent |
| K000890 | CHAD THERAPEUTICS OXYMATIC MODEL 401 | Jun 16, 2000 | Substantially Equivalent |
| K971889 | CHAD TOTAL O2 DELIVERY SYSTEM | Nov 17, 1997 | Substantially Equivalent |