T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
FDA 510(k) clearance K851215 · decided 1985-06-18
Clearance details
- K-number
- K851215
- Device name
- T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
- Applicant
- Penox Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-26
- Decision date
- 1985-06-18
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- CAM
- Device class
- 1
- Regulation number
- 868.6885
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Pittston, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| YOKE ASSEMBLY MEDICAL GAS (K935283) | American Gage & Medical, Inc. | 1994-03-11 |
| PENOX DUAL FLOW MINIFOLD (K851217) | Penox Technologies, Inc. | 1985-06-18 |
| FILL HOSE SAFETY ADAPTER (K851219) | Penox Technologies, Inc. | 1985-06-18 |
| PENOX DUAL FEED MANIFOLD (K851216) | Penox Technologies, Inc. | 1985-06-18 |
| GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB (K840326) | Siemens Elema AB | 1984-06-07 |
| OXYGEN/NITROUS OXIDE OUTLET (K780365) | Spica, Inc. | 1978-03-30 |
| OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE (K770426) | Bel-Med, Inc. | 1977-03-15 |
Recalls involving this device
No recalls on record reference this clearance.