The following data is part of a premarket notification filed by International Biomedical with the FDA for Infatherm Disposable Infant Warming Mattress.
| Device ID | K221653 |
| 510k Number | K221653 |
| Device Name: | InfaTherm Disposable Infant Warming Mattress |
| Classification | Pack, Hot Or Cold, Disposable |
| 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 | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-07 |
| Decision Date | 2022-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850018561587 | K221653 | 000 |