HOOD, INFANT OXYGEN
FDA 510(k) clearance K780220 · decided 1978-04-10
Clearance details
- K-number
- K780220
- Device name
- HOOD, INFANT OXYGEN
- Applicant
- Shiley, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-10
- Decision date
- 1978-04-10
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- FOG
- Device class
- 1
- Regulation number
- 868.5700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| OLYMPUS NA-10J-1 ASPIRATION NEEDLE (K973128) | Olympus America, Inc. | 1997-11-18 |
| BURLEW INFANT HOOD (K962182) | Promedic, Inc. | 1996-07-15 |
| SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) (K955482) | Advantage Medical Services, Inc. | 1996-01-30 |
| ENDO-GUARD (K830781) | Jayco Pharmaceuticals | 1983-03-31 |
| DISPOSA-HOOD (K792144) | Utah Medical Products, Inc. | 1979-12-05 |
| OXYGEN HOODS (K791861) | Ann Arbor Plastics, Inc. | 1979-10-04 |
| RT-HOOD (K790860) | Plastics Supplies & Products | 1979-05-29 |
| DUODENOSCOPE, MOLEL TX-6 (K770754) | American Cystocope Makers, Inc. | 1977-04-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BJORK-SHILEY CARDIAC VALVE (P780008/S013) | Shiley, Inc. | 1986-10-31 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S014) | Shiley, Inc. | 1985-04-09 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S015) | Shiley, Inc. | 1984-11-26 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S011) | Shiley, Inc. | 1984-05-15 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S007) | Shiley, Inc. | 1983-05-20 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S005) | Shiley, Inc. | 1982-02-05 |