The following data is part of a premarket notification filed by Rci, Inc. with the FDA for Concho Pediatric Pack.
| Device ID | K820878 |
| 510k Number | K820878 |
| Device Name: | CONCHO PEDIATRIC PACK |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | RCI, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-30 |
| Decision Date | 1982-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14026704611376 | K820878 | 000 |
| 14026704628282 | K820878 | 000 |
| 14026704628275 | K820878 | 000 |
| 34026704628255 | K820878 | 000 |
| 14026704628244 | K820878 | 000 |
| 24026704559330 | K820878 | 000 |