510(k) K770426
- Device
- OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE
- Applicant
- Bel-Med, Inc.
- 510(k) number
- K770426
- Product code
- CAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-03-15
- Date received
- 1977-03-07
- Regulation
- 868.6885
- Classification name
- Yoke Assembly, Medical Gas
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3008341245
- 9710641
- 3010202439
- 9611102
- 2020550
- 8022611
- 1836161
- 2020813
- 1529989
- 3003481016
- 3014437893
- 1058031
- 3006786326
- 3005347827
- 3020751316
- 3005182235
- 1526809
- 1924066
- 3007494890
- 1119231
- 3008281139
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CAM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935283 | YOKE ASSEMBLY MEDICAL GAS | American Gage & Medical, Inc. | 1994-03-11 |
| K851215 | T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER | Penox Technologies, Inc. | 1985-06-18 |
| K851216 | PENOX DUAL FEED MANIFOLD | Penox Technologies, Inc. | 1985-06-18 |
| K851217 | PENOX DUAL FLOW MINIFOLD | Penox Technologies, Inc. | 1985-06-18 |
| K851219 | FILL HOSE SAFETY ADAPTER | Penox Technologies, Inc. | 1985-06-18 |
| K840326 | GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB | Siemens Elema AB | 1984-06-07 |
| K780365 | OXYGEN/NITROUS OXIDE OUTLET | Spica, Inc. | 1978-03-30 |