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 |