The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Burlew Infant Hood.
| Device ID | K962182 |
| 510k Number | K962182 |
| Device Name: | BURLEW INFANT HOOD |
| Classification | Hood, Oxygen, Infant |
| Applicant | PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | FOG |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-06 |
| Decision Date | 1996-07-15 |
| Summary: | summary |