BURLEW INFANT HOOD
FDA 510(k) clearance K962182 · decided 1996-07-15
Clearance details
- K-number
- K962182
- Device name
- BURLEW INFANT HOOD
- Applicant
- Promedic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-06
- Decision date
- 1996-07-15
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- FOG
- Device class
- 1
- Regulation number
- 868.5700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mccordsville, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Promedic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| HOOD, INFANT OXYGEN (K780220) | Shiley, Inc. | 1978-04-10 |
| DUODENOSCOPE, MOLEL TX-6 (K770754) | American Cystocope Makers, Inc. | 1977-04-28 |
Recalls involving this device
No recalls on record reference this clearance.