The following data is part of a premarket notification filed by International Biomedical with the FDA for Nxtgen Infant Transport Incubator.
| Device ID | K220742 |
| 510k Number | K220742 |
| Device Name: | NxtGen Infant Transport Incubator |
| Classification | Incubator, Neonatal Transport |
| Applicant | International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Contact | Amy Pieper |
| Correspondent | Amy Pieper International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850018561013 | K220742 | 000 |
| 00850018561020 | K220742 | 000 |